4 Ways Technology Can Optimize Clinical Trial Workflows

4 Ways Technology Can Optimize Clinical Trial Workflows

In 2003, the cost to fully develop an FDA approved drug was $803 million. Now, however, that price has skyrocketed up to 2.6 billion and there have been no signs of this rate slowing down!

Unfortunately, while the price to develop drugs have increased, the rate of clinical trial success has decreased by about 12% in this span.

Therefore, this results in ever-increasing pressure to increase efficiency and reduce costs of clinical trials, which can be a major catch-22.

Site directors and managers are fighting an uphill battle to minimize complexity, ensure compliance, and streamline clinical trial processes.

On the other hand, there’s still a practical, regulatory, and ethical obligation to ensure data accuracy and scientific validity.

Clinical trial workflows – or the series of repeatable tasks required to finish a trial – are essential for effectiveness, reliability, and efficiency.

Women using advanced technology for organizing data.

Automation and workflow technologies help improve workflows…

…but they also may be challenging to implement. What you need to think is, will this all be worth it? The answer is yes.

After all, the majority of pharma companies don’t have in-house teams of software developers ready to take on the challenge of designing workflows which actually keep costs down and reduce complexity.

There are also stringent privacy and regulatory expectations that can impact pharma trials’ priorities.

Still, if they can be merged with existing systems, automated workflows eliminate repetitive, and manually intensive processes.

This simplifies data gathering and analysis, improves communications and productivity levels, and facilitates accurate tracking and reporting on process steps and completion dates.

In order to achieve these benefits, pharma companies will need to break through some of the above barriers sooner than later!

Team members in a meeting using advanced technology.

Here Are 4 Ways Technology Can Optimize Clinical Trial Workflows

Trials generate enormous amounts of data. This information is key to identifying operational bottlenecks and generating insights into how current processes could improve.

But to make use of it, pharma companies need to be able to see it, analyze it and put it into action.

Despite the emergence of digital technology in pharma, many companies still lean heavily on paper documentation or traditional tools such as manually created spreadsheets to manage information and patient records.

There are plenty of problems with this traditional approach, including:

  • Not fast enough.
  • It’s historical. (i.e. you can only use it to examine data from the past, or that has already been recorded and stored)
  • It’s prone to user error, inaccuracies, and data loss.
  • It’s harder to share with all stakeholders – you’ll need to configure access to online databases, ensure version control, or deal with paper copies. (none of which are ideal)

Software that can automate record-keeping processes and keep track of systematic workflows doesn’t just save time short term but they also make it easier to make good business decisions that affect the entire pharma life cycle.

To be more specific, here are 4 areas in which it’s possible to use digital emerging technology to cut costs, reduce information solos, and take advantage of automation to make clinical trial workflows more effective.

Device for reaching out to physicians for pharma sales reps.

1. Systematizing Trial Startup and Site Selection

Site selection and study startup are among the slowest and least efficient phases of clinical trial management.

Country selection, site selection, budgeting and contracting, regulatory constraints, and finding enrolling participants all take significant effort and time.

Automation can support study startup planning by outlining systematic tasks in order of urgency. Workflows can be designed based on country-specific regulations as well as individual sites, roles, and activities.

Technology can also be used to recruit patients. For example, one study found that a workflow could be designed to flag potentially eligible patients from routine health information system data in a hospital setting.

To name a few more examples:

  • Process automation can create an automatically updated virtual calendar where upcoming documentation needs to streamline trial startup procedures.
  • Databases can help automatically identify investigators with previous sponsor relationships and identify whether additional documentation of finances, licensing, and other disclosures are up-to-date.
  • Analytics and CTMS platforms can also assemble and visualize data from multiple sites at once, providing organizers and sponsors with accurate, real-time information on site performance.

A study found that inefficiencies often arise from the difficulty of measuring and predicting site performance early on during a trial, software that can identify low-performing sites can also help prioritize investigator time.

Allowing investigators to shut down unproductive sites early, or recommend monitors to visit high-risk sites over others, could save hundreds of thousands of dollars in wasted time and energy.

Physician going through data for making decisions.

2. Reducing Repetitive Tasks and Eliminating Bottlenecks

Clinical trials involve lots of workers, many of whom are highly-skilled, MD or Ph.D. – level researchers. Their time is expensive, and when it is primarily spent conducting the same tasks repeatedly, it ends up being wasted.

Common tasks of theirs include creating contracts, processing adverse event notifications and follow-ups, recording patient information, or drafting protocols.

Clinical trial site staff and investigators also often spend significant time inputting data into CRO systems with vastly differing systems for reporting AEs/SAEs and other data.

Although not all of these tasks can be automated, many of them can.

One immediate benefit of optimizing workflows with technology is through standardizing digital tasks, and automating some of the data captures. For example, scheduling patient repeat visits automatically or automatically populating patient data into the online record.

Workflow automation can also generate standardized contracts drafts to replace having to manually rewrite them for each trial. Other tools can compare patient records with previous entries to identify missing data points and potential errors in real-time.

While there’s an initial hurdle to get over when it comes to implementing a solution to do this, automating these tasks saves both effort and cost. When done well, they also reduce compliance errors and eliminate unnecessary delays.

Team of sales reps in a meeting using advanced analytics.

3. Improving Visibility and Business Decision-Making

Clinical trials are, first and foremost, designed to produce information.

To support this goal cost-effectively, all operational processes must be designed for optimal workflow and efficiency, so that:

  • Trials proceed on schedule.
  • All staff roles are defined and well-understood.
  • Important projects and tasks don’t get forgotten.
  • Resources are prioritized effectively and directed at the correct tasks.
  • Process inefficiencies are identified and eliminated.
  • Bottlenecks are removed.

In order for sponsors to achieve these goals, managers need tools to see how trials are progressing and analyze this information in real-time.

Armed with good information, they can address problems as soon as they emerge and allocate limited resources effectively. This requires deep analysis of performance across multiple areas and roles in a trial, from regulatory compliance to site selection, patient recruitment, and daily data collection activities.

Unlike previous traditional tools, which only facilitate analysis after-the-fact, pharma analytics software allows forecasting and immediate visibility of all trial processes. A single workflow program can accomplish this goal.

For example, by segregating and analyzing raw data under a single platform, our pharma data analytics solution lays out everything in a clear and concise way to allow your team to more efficiently do their job.

Using a technological tool to align your daily work with the most important objectives in the study leads ultimately to more efficient work, better enrollment, higher retention, and higher compliance rates – and in the end, that results in faster and more cost-efficient clinical trials.

Artificial Intelligence being used for actual business insight.

4. Regulatory Compliance & Study Validity

Approximately 35% of clinical research costs are spent on compliance.

Meeting regulatory constraints on the first try, rather than after trial and error, significantly lowers this cost and can shorten a trial’s timeline.

Data-driven strategies using analytics and other tools can help improve quality outcomes by eliminating compliance issues.

Data standardization – created through designing effective workflows – is also key to ensuring the reliability of the overall trial, particularly when trials go global.

You are much better off in a Medicare or financial audit when you design workflows that collect data along the way and then organize that data logically whenever the workflow is finished.

When paperwork gets lost or forgotten on someone’s desk, or there are errors in recording it, audit inspections can be delayed, leading to further headaches.

In contrast, when your data are organized and reported within a single software-based source, the auditing process is faster and far less painful for all involved. An advanced pharma CTMS software solution will keep track of anything from financial records through consent from the documentation.

Physician using tablet device.

Automation Removes Bottlenecks and Streamlines Workflows

The potential of digitizing and automating common pharma tasks is still in its infancy.

Pharma companies are often reluctant to change processes, given the challenges of adopting new technology to old regulations and strict compliance guidelines.

Still, in order to compete and counteract the skyrocketing price of developing new medications, reducing inefficiency and looking for ways to streamline clinical trial operations is unavoidable.

With the tools already out there, it’s already possible to:

  • No longer enter data and assign tasks associated with running a clinical trial manually or traditionally.
  • Identify and reduce the current bottlenecks relevant to your organization.
  • Create standardized workflows designed to make start-ups easier, eliminate delays, and implement study protocols faster.
  • Identify cost- and time-saving opportunities.
  • Improve visibility and streamline collaboration between team members.
  • Keep data gathering auditable and compliant with current regulations.

Also, if you’d like to learn more about our CTMS solution or our analytics and data management solution, contact us below for free!

4 Ways Pharma AI Enhances Medication Delivery Methods

Whether it was from movies, books, or on the internet, you’ve most likely heard of therm “Artificial Intelligence” or AI.

Maybe you know if it as nothing more than just a buzzword, but trust us when we say it is much more than just that. Especially in the pharma industry.

In 2018, the global AI market in healthcare was about $1.4 billion and it is expected to grow to approximately $17.8 billion by 2025.

This expected growth in healthcare shows how much of an impact the technology can have in various areas within the industry and its importance going forward.

So, what are the ways AI can be used in pharma and your company? One of the most popular ways you’ve probably heard about is with assisting in drug discovery. However, that’s not the only way AI can make be beneficial for pharma companies.

TIP: If you’re interested in learning more about the other ways AI is beneficial to your pharma company other than with drug discovery, check out this blog we created!

Another major area where AI is beneficial is with being paired with drug delivery methods to enhance outcomes.

4 Ways AI Can Enhance Medication Delivery Methods

  • Precision Medicine: Takes genetics into account to diagnose/treat and physicians can more precisely foresee how well patients will respond to specific treatments.
  • Virtual Nurse Assistants: Has the ability to lower the number of hospital visits that are labeled as unnecessary. This technology can provide patients with 24/7 access to support and monitoring, as well as the ability to receive answers to questions they may have about their medications very quickly.
  • Robotic Surgery: With artificial intelligence, robots can use data from operations done in the past to make decisions on new surgical procedures.
  • Health Monitoring Apps: AI-enabled health monitoring apps support individual patients with a step-by-step guide through the patient journey and provide HCPs with the data to help guide them. Wearable devices are another form of digital health that can track heart rate, activity, sleeping patterns, and more.

Below is an infographic displaying 4 different ways pharma AI can enhance medication delivery methods:

pharma ai

Also, if you’d like to learn about our Artificial Intelligence built on a Microsoft platform and how the technology can strongly benefit your pharma company, contact us below for free!

4 Challenges With Managing Clinical Trials & How Technology Can Help

The skyrocketing costs of clinical research are likely the first issue that comes to mind when it comes to barriers to pharma companies’ R&D efforts.

In 2014, the Tufts Center for the Study of Drug Development found that clinical testing costs as much as $2.6 billion per drug; the cost of drug development has increased by 400% in less than two decades.

However, ongoing research challenges are affecting far more than pharma companies’ bottom lines. To name just one high-profile example:

Pfizer recently realized that patients taking one of their arthritis drugs might have reduced risk of developing Alzheimer’s. While that seems like positive news, the company ultimately opted out of testing the correlation. This was due to the risks, difficulties, and cost of R&D not being worth the potential upside.

This case reveals a growing reality within the pharma industry – clinical trials are an essential step towards bringing new drugs to market and driving value, but they are facing increasingly pressing challenges, not only including costs but also:

  • Time: Also, the average testing process takes up to 14 years, so drugs may have only a couple of years on the market before they face generic competition.
  • Complexity: Increasing trial complexity influence both the cost and quality of the research. Testing drugs sometimes requires hundreds of sites, complex protocols, and the involvement of hundreds of highly qualified professionals.
  • Risk Management: Standardizing clinical trial processes to comply with regulations requires extensive planning and IT sophistication.

In situations like the one, Pfizer faced, everyone loses – the patients, who miss out on potentially life-saving treatments, the insurers, who have to pay more for drugs that cost more to produce, and the pharma companies, who have shrinking windows for patented drugs and who face R&D costs spiraling out of control.

Unpacking the specific barriers facing clinical trials – and how to overcome them using the most innovative solutions available – is key to meeting efficiency goals and continue to add value.

4 Challenges With Managing Clinical Trials & How Technology Can Help

Top Challenges Affecting Clinical Trials & How to Solve Them With Pharma Technology

1. Regulatory Barriers and Approval Delays

Given how tightly regulated the pharma industry is, meeting compliance obligations is unsurprisingly among the top challenges getting in the way of timely and cost-effective clinical trial completion.

Especially as trials move globally, they become increasingly constrained by their own complexity. The need to coordinate between multiple sites, partners, and vendors are becoming exceedingly challenging.

In a survey including pharma executives by ICON and pharma intelligence, 43 percent of respondents named regulatory approval delays as the most common challenge.

Even steps as fundamental as version control on consent form documentation can turn into major deviations from protocol – a regulatory disaster – if data isn’t correctly stored and organized.

In fact, more than one-third of clinical research spending goes to keeping trials compliant.

Organizing information using a CTMS software keeps track of all information from the beginning, standardizing your record-keeping and who is authorized to do what, and when.

Analytics tools not only keep you protected in an audit but also make delays less likely, as well as streamlining the entire approval process.

An effective CTMS software will keep track of anything from Sunshine Act reporting through consent form documentation, and make it easier to define investigator and support staff roles at a site-level.

These tools also centralize site activation mechanisms, making it possible to instantly share important records with stakeholders.

Once a trial is underway, record-keeping systems also help keep track of scheduled dates for ethics/IRB submissions and approvals, helping to keep study timelines on track.

Clinical trails

2. Site Selection & Recruitment

About 2 million patients participate in clinical trials every year, but to meet U.S. recruitment goals, 6 million patients would be needed. This reality causes delays or budget issues in as many as 90% of trials.

Recruiting and retaining enough participants to complete a trial is among the biggest sources of delays and trial failures.

Site selection is a critical first step to patient recruitment, and some of the most important parameters for site selection are patient access, infrastructure, and suitability for the given treatment type.

However, according to research done at Tufts, the number of PIs available to conduct research has consistently declined over the past several years.

This makes it more challenging – and more important – that pharma companies have the tools to identify available investigators who have the highest enrollment potential.

Artificial Intelligence or AI can draw operational data from previous trials to predict site performance in the future. Eventually, it may even be able to predict retention, trial success, and whether a drug will result in positive outcomes.

Today, however, using the right software makes it possible to re-use information from a site across multiple trials, reducing the time it takes to select and then initiate a site.

When the same patient population becomes known, these tools can also support increased engagement and better relationships over time.

Clinical Trials

3. Clinical Trial Site Management

Clinical trials have been growing increasingly complex for years.

As the complexity, geographic diversity, and rate of change in trials increases, it becomes more difficult to make decisions and identify potential issues in real-time.

Roles and responsibilities among staff members evolve quickly, and lack of visibility into data, as well as dealing with disparate data sources, makes it touch to respond quickly.

About two-thirds of clinical trial coordinators say they use manually compiled spreadsheets to make business decisions.

This leads to slower problem resolution and an inability to identify underperforming sites (leads to more delays).

Using a CTMS, you can easily generate reports on study progress, financial metrics, staff hours, enrollment goals, protocol deviations, and adverse events.

This software enables centralized monitoring, real-time reporting, rather than shuffling papers and trying to compare sites after the fact or in cumbersome ways.

Clinical Trials

4. Data Management

When trials are underway, ensuring that sites are well-monitored, and data is being accurately captured, is one of the most important priorities of trial management.

Ensuring patient perseverance and completion of the clinical trial protocol requires active data analysis and monitoring to track compliance, including monitoring of endpoint data, deviations, and any adverse events.

Doing this manually, as many pharma companies still are, leads to difficulty updating information quickly and aggregating data from multiple sources and across different systems platforms.

Lab results, imaging, and health records are difficult to integrate quickly, especially with site directors relying on manual spreadsheet methods.

Software for clinical data management has the advantage of instantly centralizing the information, making it accessible by key personnel quickly.

The right solution can integrate across disparate data sources in near real-time, enabling proactive response to SAEs/AEs and seamless monitoring of protocol compliance.

Data managers can also automate result reporting, making it easy to look for trends in patient responses sooner.

clinical trials

Traditional Methods of Clinical Trial Management Aren’t Working Anymore

In the past, clinical trial activities such as…

  • Patient Recruitment
  • Site Selection
  • Intervention Delivery
  • Compliance and Record-keeping
  • Data Collection
  • Etc.

…were all completed using paper-based, traditional methods.

Even though online tools have been available for record-keeping for over two decades, clinical trials have been slow to adopt them.

Today, less than 10 percent of clinical research professionals report having access to the software tools that enable automation of these initiatives.

This should be too much of a surprise given the long lifecycle of drug development being eclipsed by the evolution of digital tech and that pharma is such a regulated industry.

However, given how pressing the challenges currently facing clinical trial management are becoming, using modern tech solutions is the best – and possibly the only productive way to improve diverse areas of research, such as:

  • Overall study quality and validation
  • Risk-management protocol and risk-based monitoring
  • Centralizing of study data and monitoring
  • Site selection and management
  • Site Selection
  • Patient Recruitment and retention
  • CRO oversight
  • Time management

Tools like Artificial Intelligence, Data Analytics, and CTMS software all reduce the risk of extra cost and delays. Data analysis enabled by these technologies can also reduce overall expenditures and improve the efficiency of future studies.

Clinical trials require a balancing act of speed and delivery against the quality of data and processes to deliver the safest product. Often, the right software makes the difference in this balancing act.

If you’re interested in our CTMS solution for your clinical trials, contact us below for free and let’s chat about it!

Solutions For Improving Data Quality & Avoiding Delays From a Clinical Trial Site Manager

Laptop with clinical trials data

In all clinical trials, one of my ultimate goals is to obtain accurate, clean data as quickly and efficiently as possible – all while minimizing overall trial costs.  Although the trial data results are the end goal, I never want to sacrifice subject safety to get it. 

Subject safety is the reason we follow the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP).  Institutional Review Boards (IRBs) are in place as a means of ensuring we follow ICH/GCP throughout the life of a clinical trial. 

To remove bias, third-party vendors monitor and verify clinical trial data.  It is this vendor, often a Clinical Research Organization (CRO), that is responsible for sending out Site Managers (SMs) to perform monitoring visits at all sites chosen to participate in the trial.  During these visits, SMs review source data for accuracy and completeness. 

SMs ensure that site staff have been compliant with the protocol, verify Principal Investigator trial oversight, perform drug accountability, verify documented site training and can work with the site staff to reconcile any discrepancies noted.  At the completion of a visit, the SM leaves the site as ‘audit-ready’ as possible.

As SMs have many responsibilities, it is easy to see that there are many ways in which trial data delays can occur.  As a former Lead SM and now a Clinical Operations Lead, I have learned that one of the most basic ways to lose time in a clinical trial is by having the monitoring visits occur out of the scheduling window. 

What is the Problem?

We can only rely on clinical trial data entered after a SM has verified it.  Therefore, it is crucial to have monitoring visits occur according to the timing schedule found in the Clinical Monitoring Plan (CMP) / Clinical Operations Plan (COP).  When these visits do not occur within the scheduling window of the CMP/COP, it leads to untimely source document verification (SDV). 

Untimely monitoring visits can create a multitude of problems during clinical trials.  In my experience, a delay in SDV has a negative chain effect.  Other clinical departments (i.e. Safety, etc.) are unable to perform their review until after the SM has performed SDV.

This prolongs the time it takes for overall trial data reconciliation.  The Data Management department may also spend an endless amount of time querying unverified/unclean data unnecessarily.  This is not just a poor use of time but can be a very costly endeavor for pharmaceutical/sponsor companies. 

During the SDV process, SMs often find unreported Adverse Events (AEs) and/or Serious Adverse Events (SAEs).  SAEs require reporting to the sponsor company and the IRB within specific timeframes.  As mentioned earlier, subject safety is my highest priority during any clinical trial. 

Therefore, prompt assessment and documentation of AEs and SAEs is a must.  If monitoring visits are not occurring according to the CMP/COP, I cannot ensure this.  Any delay in SDV can also lead to protocol deviations going unnoticed and possibly repeated for subsequent subjects at multiple subject visits. 

What is the Remedy?

In our very technologically savvy world, there is any number of calendar date generating applications and websites one can choose.  I have used the following website when I do not want to be relegated to the use of a ‘date wheel’:  https://timeanddate.com.

There is even an associated phone application for iOS called ‘Time & Date Calculator’.  Both the website and phone app require me to enter the date of the initial visit and then the number of weeks/days/months required in the interval.

Once I enter that information it will calculate when the next visit should occur.  If I need to create something more tangible for my SM team, I input a trial-specific formula into an Excel spreadsheet. 

This enables anyone on the clinical study team to generate the same information as the above-mentioned website, which is helpful when SMs need to forecast future monitoring visits. 

Whichever method is chosen, I know that I am creating a check and balance system that can minimize the timing of trial data available for further analyses.  CROs can use these measures to ensure that their employees are following the CMP/COP and to hold trial sites to their contractually agreed upon availability. 

Likewise, pharmaceutical/sponsor companies can use these methods to verify that a CRO is adhering to their contractual obligations for overall trial monitoring.  Most importantly, though, by finding a method that works best – it will aid in getting clean trial data submitted in a timely fashion.

If you would like to learn about our Clinical Trial Management System tool and how our solution can help solve problems such as this one, click below!

How to Streamline Your Clinical Trial Management with Cloud Technology

abstract-cloud-technology-system-sci-fi-background_115579-771

It goes without saying, that clinical trials are an incredibly important aspect of the pharmaceutical industry as a whole. But, unfortunately, they are the furthest thing from inexpensive or easy to manage.

In fact, it was reported that the total cost to implement and conduct a large-scale clinical trial can be anywhere from $300 to $600 million, with the total cost increasing a few million each year. But unfortunately, that’s not all.

On top of all of the financial costs, research conducted at the Tifts Center for the Study of Drug Development reported that the average development time for clinical trials is 6.7 years!

Now, the good news is that there is a legitimate solution to simplify clinical trials.

Here is a basic outline on how to streamline your clinical trial management with cloud computing technology: 

First Off, What is Cloud Computing?

Cloud computing is the centralized management of data and applications on virtual and internet-based servers. When offered by a third party vendor, they’re often referred to as cloud-managed services.

Now, you may be wondering, “How can cloud computing benefit clinical trials? How can it be a solution to all the issues?” That’s exactly what we’re here to answer!

Cloud Computing is rapidly transforming the way clinical researchers retrieve data. With the wide variety of mobile and cloud-ready devices we have available to us, it’s almost unheard of to not use the cloud to store your personal data. You know it’s safe in case of any emergencies. So, why not leverage the cloud to store and access business data?

Successful woman using cloud computing with her laptop

HIPAA compliance and data security have long been a major concern for pharma and healthcare organizations venturing into the cloud. However, strides have been made in this department as well, which we will discuss a little later. 

Devices such as smartphones and fitness wearables make it possible to electronically collect data directly from clinical trial participants. This allows clinical researchers to skip many of the annoying but required steps to collect this data.

Traditionally, this process would involve tons of folders to store data, constant struggles with recruitment, disorganization, high costs, and a ton of risks. Cloud computing puts an end to all of that.

Cloud Based CTMS

Unlike a traditional Clinical Trial Management System (CTMS), a cloud-based CTMS doesn’t require companies to purchase servers, install applications, validate, document, and maintain everything in-house. This means that you no longer have to wait months for IT to implement a CTMS. Altogether, saving you so much time and stress.

Here is the process of a CTMS:

On top of those benefits, with a cloud-based CTMS, payments are usually lower over a five-year period and spread out monthly or quarterly. This provides greater flexibility and reduces many of the risks associated with a clinical drug trial. 

Data security has always been pharma’s biggest concern with cloud technology. But, with recent security and storage advancements over the years, he risk has been significantly reduced.

Conceptual digital image of lock on circuit background

While this technology isn’t “perfect,” it’s well on its way! 

Still not convinced that a cloud-based CTMS can significantly improve how clinical trials are conducted? Not to worry, we will dive much deeper into how cloud computing can make clinical trials run more efficiently while providing better results in a major way.

First, it’s important to understand the Clinical Trial phases and the unique caveats that come with each stage.

Let’s Take A Look At the Basic Clinical Trial Process 

Before diving into the different phases that a clinical trial consists of, these seven questions should always be asked….

This checklist gives clinical researchers a better idea of how to run the trials and what kind of results hey can typically expect. Also, if your client is running the clinical trial, mentioning this to them before going into what your CTMS can provide, would earn you some nice brownie points. 

For every drug that’s been FDA approved, it has gone through these phases.

As you can see, as the drug progresses through each phase in the process, the length of each phase gradually increases. But, that’s not the only thing that grows. 

In a survey based on data from Cutting Edge Information, Quora reported these estimated costs per phase in 2013:

  • Phase 1: $38,500
  • Phase 2: $40,000
  • Phase 3: $42,000
  • Phase 4: $16,500

With the exception of the final phase (when the market is tested with the new drug), the cost of each phase increases. These prices do not even reflect the low percentage of companies who successfully move on to the next phase.

So, if a drug didn’t make it past phase 2, the price of $42,000 for the transition into phase 3 would double, or it could multiply even more depending on the circumstances of the trial.

On top of costs steadily climbing, think of how many participants are involved with each phase (see above chart in each phase description for the amount of volunteers). If the massive amount of collected data isn’t organized and analyzed correctly, the drug will fail more times than not.

That’s where cloud computing for clinical trials comes into play.

How Cloud Computing Affects the Organization of Information

Easily Organize Clinical Trial Data in one place

“Cloud-based EDC (Electronic Data Capture) software provides even more efficient data monitoring and reporting, enhanced communication and collaboration, and better budget forecasting,” said Cynthia A. Challenger, Ph.D.

Clinical researchers can often be overwhelmed by the sheer number of data sources for each trial, such as social media and wearable technology. The integration of cloud technology for clinical trials can easily aggregate and store all of this data and every person can input feedback at their convenience.

This results in one place for authentic, high data quality, and accessible information that can make collaboration easier.

Yet, the adoption of the right cloud computing software or cloud-based EDC doesn’t just store the massive amounts of data in one place, it also does so much more! It provides real-time visibility combined with the ability to do the following with data:

  • Process
  • Analyze
  • Evaluate
  • Instantly share results with relevant stakeholders

With a clinical trial cloud system, data from a study is collected from around the world and patient smartphones and stored in one convenient place. Having this data stored in the cloud offers built-in error management protocols and collects all the information in real-time. Which results in no delays and faster results.

Businessman drawing business plan on glass window with bokeh background-1

What does this mean for clinicians? 

It means less sitting through thousands of paper Case Report Forms (CRFs) from different sites, transferring tons of data into spreadsheets to be analyzed, and best of all, no more stressing.

The FDA actually encourages companies to use cloud-based systems for organizing their clinical trial data, because it enables the sharing of more accurate data between:

  • Sponsors
  • Investigators
  • Patients
  • Regulators

This increased level of data sharing leads to increased compliance and reduced clinical trial costs.

To sum it up:

One centralized data storage location receiving and archiving feedback can exponentially speed up how clinical trials are run.

Another benefit of cloud computing with CTMS is how to secure the data that’s being used is kept.

At one point, this was a huge concern with cloud technology. But, over the years, significant advancements have been made to improve the overall security in the cloud and ensure that everything is HIPAA compliant.

How does Cloud Computing Help with Data Access for Clinical Trials?

Increased Data Security Measures

We’ve all seen the computer hacker scenes in movies….

Hacker programing in technology environment with cyber icons and symbols

It seems so cool, but the last thing anybody wants is their clinical trial data to be hacked and sold to the highest bidder. Over the years, cloud technology has drastically improved its security measures to reduce risk and improve trust. 

In fact, most people believe that data security with the cloud has surpassed the security of data hosted on-site.

The confidential participant data is located in a secure data center and there can be multiple layers of security applied to protect sensitive patient data from prying eyes.

Cloud computing for clinical trials allows employees to access the same applications and documents no matter where they are and converts any location into a “virtual” office.

Simplified Subject Recruiting 

In less than ten years, the number of registered clinical trials jumped from 50,000 in 2007, to more than 180,000 in 2014. Yet, during that time, about 85% of those trials were delayed or unfinished because of a lack of participants.

The good news is that there is a solution! 

One key way that clouds computing helps pharma companies recruit participants is with “big” data.

As mentioned above, data that are stored in the cloud can be shared with anybody with proper access. That includes the data of certain patients and their qualifications for certain trials.

Cloud-based recruitment benefits hospitals and healthcare companies by increasing the awareness of the clinical trials that are being held and improves collaboration saves time and facilitates the research by the end-users.

It also benefits pharma companies and contacts research organizations (CROs) by streaming trial design and procedure based on eligible patients and lowering R&D cycle time and costs.

Blood giving at hospital

Boosts Subject Tracking Measures

A huge amount of data has to be collected on these patients to qualify for a clinical trial. To simplify the process, cloud computing can generate data from:

  • Social Media
  • Fitness Wearables (smartphone apps and smartwatches)
  • Electronic Records
  • And so many more sources!

We live in a digital world, where a 2×2 screen on your wrist can literally determine what kind of patient you are. That’s just the way it is!

On a more serious note, all of these different devices offer a great way to track patients and their health when conducting clinical trials!

These devices enhance the following in clinical trials:

  • Patient Engagement
  • Data Quality
  • Operational Efficiencies

Plus, patient devices provide nothing but benefits for patients and the organizations in healthcare in the form of more data, educated patients, aware patients, and smoother communication between the provider and the patient.

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How Can a Cloud-Based CTMS Help Improve Study Management?

The cloud can massively assist in study management. The chart below explains how it can be used and what it can accomplish.

Better Trial Location Control 

Study Start-Up (SSU) solution is a cloud-based technology that simplifies trial location control with integrated activities:

  • Country Selection
  • Pre-Study Visits
  • Site Selection and Initiation
  • Contract and Budget Execution
  • Enrolling the First Patient

You can review and manage each trial location and how data is entered at that location, as well as monitor trial requirements in real-time, which speeds up the clinical trial process and reduces overall costs.

How Can a Cloud-Based CTMS Help with Cost Reduction? 

Simplifies Financial Management

Research from IBM has indicated that many pharma companies can reduce their annual operating spending as much as 25% on clinical IT systems by using cloud technology.

The costs of hardware acquisition, installation, provisioning, maintenance, support, and software licensing are all eliminated when using a cloud-based CTMS. You can also obtain financial disclosure, obtain medical licenses, and manage to budget.

It was estimated that per year, patient recruitment costs alone can reach more than $1 billion.

“Recruiting the required number of patients for clinical trials is a constant challenge for customers and can represent more than 30% of total study costs,” said Steve Cutler, Icon’s COO.

Additionally, it was reported that in the U.S. in 2014, clinical trials across all therapeutic areas costs $30-40 million on average before even reaching approval in phases 1-3.

By keeping data organized and enabling clinical researchers the ability to manage everything in one location, the clinical trial process speeds up and eliminates extra costs.

This is all possible because of the benefits that cloud computing offers to clinical trial management.

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So, how can a cloud-based CTMS provide clinical researchers the ability to run trials more efficiently and effectively? A cloud-based CTMS can: 

  • Reduce Costs
  • Reduce Maintenance
  • Reduce Risks
  • Increased Reliability Across Multiple Phases
  • Reduce Hardware Requirement, Costs, and Maintenance
  • Simplify Recruitment

As does the digital technology we personally use on a daily basis, a cloud-based CTMS offers more control and flexibility with each study! Ultimately, providing information and results that improve the health of patients worldwide.

By looking at the charts and facts said in this article, you can gain a ton of insight on….

  • Questions that should be asked before beginning to form a clinical trial: Whether this is for a client of yours and you are supplying the cloud technology for their trials,or you’re a clinical researcher, these questions must be asked! It gives a greater perspective on what can come from the trial and how to properly go about conducting it.
  • The clinical trial phases that must be done before receiving FDA approval: When doing business with somebody, it’s always best to relate to your customers/clients. So, if you’re services are being sold to those who conduct clinical trials, you should know the phases they have to go through in order to successfully launch a drug.
  • Struggles that exists around patient recruitment for clinical trials: For a trial to exist and results to be shown, you need participants, there’s no question there. The traditional way of recruiting is hard and costly. The cloud helps with that. The graph shows the percentage of struggles that occur in recruiting. Thus, giving you a better idea for how you can assist your clients even more.
  • How to manage your study with the cloud: While most internet searches may not be helpful in determining how cloud computing can help manage your study, our above chart simplifies the answers. You can more easily collect data, manage that data, reduce on-site work, improve trial visibility across multiple channels, simplify financial reporting, and more effectively choose a trial site.

So, after reading this, do you find yourself not only more knowledgeable on clinical trials, but also feeling more confident in how you can help your clients manage their clinical trials with the cloud?

There’s so much to talk about on this topic so please if you have any input that wasn’t stated above then please share in the comments!