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.
We sat down with Microsoft PowerBI Certified MVP and executive strategist, Belinda Allen – where she shared her insight on how enterprise application of Power BI is revolutionalizing business strategies.
This is the first part of a series with Belinda, focusing on tangible, actionable Power BI integration at the enterprise and executive levels.
During each part of this series, we are sharing two tidbits that we asked Belinda:
What is your definition of the CEO-level value-proposition of using Power BI?
“With the implementation of Power BI, C-value executives will have access to real-time analytics and knowing what is happening in the moment without having to ask anyone to provide them with updates, without having to guess on their own, and more importantly – they are no longer looking at what has happened in the past, but they can now dig into what is happening in the present to make the best decisions for the future.
We live in a world where disparate systems are a reality, and they probably will be a reality going forward while line-level managers are leveraging data. So, being able to create reports that integrate the data from multiple sources on to one common place and looking at it in real-time is something that prior to the world of Power BI dashboards was not possible or it took a long time for people to prepare reports and send to C-level executives.
The ability to look at information and make decisions quickly to look for trends, tracking data, and starting to use other resources that are available within the Microsoft family that provide intelligence and machine learning built-in is beyond invaluable for the CEO.
One of the biggest advantages of using Power BI is there’s a low cost to entry and high return on investment. So, the low cost of entry the product that is relatively easy to use for the person consuming reports and it’s very easy to share data. It’s all about the efficiency in getting data, nobody wants to sit and wait on what’s going on. We all expect everything instant in today’s technology era – and Power BI can deliver that.”
How does Power BI feed the strategies that help the executive management of an organization and make enterprise decisions?
“Being able to use sentiment analysis along with financial numbers is becoming more and more important. Sentiment analysis monitors what people are saying on social media and reviews that are left on websites such as Yelp and if they’re showing that they’re happy with your company or not. We are living in the here and now, so if you have a bad experience with a company, you’re most likely going to tweet about it and companies can now capitalize on this information with some of the tools that take sentiment analysis and do that.
The same is true when they’re looking at their CRM systems, being able to monitor what’s going on. Times have definitely changed, you can now create a correlation between complaints about your company and the revenue decreasing. Let’s say you have a ton of complaints about product “B”, you may want to see if there have been new sales for that particular product and if there is any correlation there. We don’t know what we don’t know! We have a tendency as human beings to look for data that supports our theories.
So, if we can do some analysis that takes us out of trying to build something that just supports our theories – which is what we’ve always done with tools such as Excel (creating files to prove a theory of why we are going in that direction we are headed in), we can instead look at what the data is telling us. Being able to be more fluent and go with the trends using Power BI and sentiment analysis is just invaluable.
Microsoft’s Power Platform is also very beneficial and it consists of three products – Power BI, Power Apps, and Flow. Power Apps is a mini-app building tool that enables you to create an app to use on your desktop or on your phone and it can be something very complex that a developer would build or something more straightforward. And you build those out using the single functioning formulas similar to the way you do an excel spreadsheet. So, if you’re comfortable with Excel, you can build your own apps inside of Power Apps. I bring this up because you then can take something built-in Power Apps and put it inside your Power BI report. Or you can take Power BI visuals and put them inside your Power App.
Then you can take advantage of a third product called Flow. It’s an integration tool or workflow tool – it’s a way to bridge things together between multiple applications. Let’s say you are in Dynamics 365 and somebody has a problem with your company. After a case has been resolved in Dynamics 365, Microsoft Flow can automatically send out a form and if someone responds saying no they weren’t satisfied then new questions can appear so you can drill down on the issue and if it’s an open-ended question which I completely recommend then whether or not the answer was positive or negative can be tracked and analyzed, so you can really get to the heart of the matter.
In days past, we would have to read all of the comments/answers to get an idea of what’s going on, now, Microsoft machine learning has the ability to go through all of that text automatically and assign based on shift in tense, all capital letters, and other signs of negativity. You can have this tool go through social media comments, YouTube comments, blog comments, etc. Or, let’s say one of your employees creates an alert using Flow, and if that alert gets activated, then I want it to send an email to the CEO of the head of sales and maybe three other specific people and I want it to include a link to a specific report or visual – and you can do that automatically with Flow. You can even set parameters where if the number being analyzed is less than a certain value, the alert can only be sent to certain people. Or if it’s a value greater than you can send it to everybody.”
We are proud to be a partner with Belinda to provide her insight into the C-level application of Power BI strategies, changing the methodology of business in the life sciences. Stay tuned for the next release of insight from Belinda.
Belinda Allen is a Microsoft Certified PowerBI MVP and Gold Level Trainer, she is also the Business Intelligence Program Manager for PowerGP Online. She has excelled in assisting partners and customers to implement and create BI methodologies, enabling businesses like yours to make high-quality decisions based on real-time and accurate information. You can find out more at http://www.saci.com/.
If you would like to learn about our Data Analytics solution which includes Power BI technology and how it can help your Pharma company, click below!
In this digital age, the term “data” can often be much like a loaded question; many industries have an overabundance of raw data available but a distinct lack of understanding of how to deal with that data. The pharma and biotech industries are no exception.
The growing level of accessible, quality, real-world healthcare data is causing quite a stir throughout the pharmaceutical industry.
Recent findings indicate that applying specific data strategies to innovation optimization, improved efficiency of research and clinical trials, and transitioning doctors, insurers, and regulators to the rapidly shifting individualized, patient-centric approach to healthcare is consistently identified as a top priority among pharma leadership teams.
Pharma data collection and analytics are so essential to the future of pharma that nearly 40% of pharma professionals identified it as the most significant trend in the industry for the coming year.
Much like any other industry, there is an enormous amount of raw data available to pharma companies, but harvesting and harnessing that data can require a bit of work.
In order to remain competitive in the rapidly evolving field of pharma data, organizations must understand the following:
Which data sources available are relevant to the pharma industry.
The unique differences between these data sources.
The importance of the information provided by these data sources.
How to harness this information to benefit your company.
Primary vs. Secondary Data Sources
All data is not equal, which is especially true in the pharma industry. To simplify things, pharma data typically fall into one of two categories: primary or secondary data sources.
Primary Data Sources
A primary data source gathers information through direct interaction with the end-user and through purchased data. This type of information is obtained when…
Physicians are attended by a sales rep.
Patient participates in a clinical trial.
The patient is involved in treatment where a medical claim is generated.
Primary source data is essential as it provides vital information gathered through study, trial, testimonial, or other forms of direct interaction between a patient or provider and a pharma product.
Secondary Data Sources
Secondary data sources gather information through market research and often use data gathered in databases and registries. Examples of pharma secondary data sources include…
Various forms of social media.
Sunshine Act Database
Something to keep in mind is that secondary data source information is typically public information available for free and provides valuable information that can help you reduce costs, advance sales, and adjust the focus of your company.
Regardless of the source, both primary and secondary data provide timely, relevant, and important information essential for evaluating and identifying strategic opportunities in the overall global pharma market.
Examples of Primary Data Sources In Pharma
1. Clinical Trials
Clinical trials are advanced research programs designed to test whether a new medication, treatment option, or medical device is as effective or more effective than current devices or treatments currently used or prescribed to patients.
Recent reports estimate the average cost associated with developing a new medication to be more than $2.5 billion, with nearly 60% of costs coming directly from the associated clinical trials.
These clinical trials are essential in providing detailed information about the safety and efficacy of pharma products, indicate who is able to use and benefit from the drug and highlights important side effects, interactions, and potential dangers associated with it.
Without the data provided through the clinical trial phase, the breakthroughs realized through new pharma developments have no value and their benefits will go unnoticed.
2. Patient Testimonials
It’s no secret that patients are the ultimate beneficiaries of the advances in medical science that help them overcome diseases and life-threatening challenges.
However, due to the nature of the pharma sales process, more often than not, pharma companies aren’t able to make a direct connection with the patient and rely heavily on the prescribers to educate the patients.
Over the last decade, companies have built great patient assistance programs and patient testimonials are increasingly important.
“There is no greater partner we can look for in healthcare than the patient,” says Cheryl Lubbert, President, and CEO, Health Perspectives Group. “By incorporating the patient’s voice early and often, we can expect better health literacy, better adherence, and better health outcomes.
In fact, patient testimonials are so effective, research conducted by Remedy Health demonstrated that…
9 out of 10 patients who have heard an inspirational story about another patient reported becoming more hopeful, which inspired them to take action.
This action includes trying a new treatment or medication, going to the doctor, exercising, or eating healthier.
3. Adverse Events
While adverse events are an uncommon occurrence, managing and tracking adverse events is a crucial data component for a pharma company to stay legally compliant with the FDA as well as to improve the conditions of future trials.
Strong, efficient data collection and analytics are an essential component to effectual sales operations for any pharma or biotech company.
This is often achieved through…
Building strong customer relationships.
Enhancing sales team performance.
Monitoring the customer’s decision-making process.
Efficiently monitoring and managing operational costs.
Sales operations and analytics software platforms within a pharma company analyze a large amount of data to develop a comprehensive promotion strategy and target universe.
Examples Of Secondary Data Sources
5. Social Media
Social media continues to transform the way the pharma and healthcare industries do business, especially in the evolving age of patient self-information.
Studies show that 80% of social media users are actively using the platform to search for health-related information. Also, over 90% of 18-24 year-olds report that they considered the health information provided on social media to be reliable.
Social media users also report sharing their first-hand experiences on a wide variety of health and medical topics over social media, including…
Coping with chronic conditions.
Treating acute illnesses.
Choosing a healthcare provider.
In addition, an increasing number of social media users are looking to their doctors to actively share information about new drugs, benefits of new medications and treatments, and updates on specific illnesses.
By engaging in social media about health-related topics, people are able to share their stories and experiences, as well as find treatment recommendations and options that have worked for others in similar medical circumstances. Social media provides a massive, active network for pharma data collection.
Companies are using these developing patient portals to glean information from end-users of pharma products and services.
Data gathered through social media channels can also help drive marketing campaigns by providing a rich well of potential marketing material such as patient testimonials and stories that when integrated into marketing materials are instantly relatable and give people the opportunity to make an emotional connection.
6. Sunshine Act Database
Each year, the Physician Payments Sunshine Act published data that discloses to the Centers for Medicare and Medicaid Services (CMS) payments made to teaching hospitals and physicians, as well as manufactures holding interests in those companies.
The Sunshine Act Database provides current data on over 28 million records related to nearly $17 billion in clinical trial-related payments to doctors, hospitals, and healthcare organizations.
Most of these payments are provided in the form of travel, research, gifts, meals, and speaking fees.
The database also details information pertaining to the ownership interests that physicians and their family members have to clinical trial organizations.
This data provides valuable information that has significant implications for the impacts of the efficiency of your organization.
A 2009 survey discovered that 84% of physicians interacted financially with drug, device, and medical supply manufacturers.
These relationships often resulted in swayed decision making that directly correlated with inflated healthcare costs.
Having access to the type of pharma data provided through the Sunshine Act Database is critical to understanding the value attached to drugs.
Are You Ready To Access Actionable Pharma Data and Analytics For Superior Outcomes?
In the current era of open healthcare information, a wide variety of valuable pharma data is available and accessible to prescribers and patients alike.
Pharma organizations that demonstrate the ability to collect, analyze, and respond to relevant pharma data also demonstrate the ability to better meet the needs of their customers/patients, accelerate innovation, and increase revenue and overall value.
We at Prescriber360 provide powerful, streamlined access to the most relevant primary and secondary pharma data sources available including:
Sunshine Act Database
We proudly serve as a premium pharma data solutions provider, allowing you to focus on your resources and efforts on implementing this knowledge, adapting to customer needs, and achieving better results and increased earnings for your business.
If you have any questions or comments, please feel free to post them below in the comment section!
Want to learn how our advanced pharma analytics and data management platform can provide you with the information you need to enhance your company’s performance? Request a free platform demo today below!
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