Meet Product Director Erin Erginer
When Erin came to P21 in mid-2021, she brought with her more than 20 years of experience in clinical research, data management, data acquisition, SDTM transformation... basically anything collected outside of a CRF.
Just prior to coming on board, she felt the frustration that she and other industry professionals at GSK were experiencing as more and more study data started originating from sources outside the traditional CRF or eCRF.
After collaborating with our Product team at P21, she felt so connected to the mission of solving problems and pain points in this space, she decided to join our team and help pioneer a new solution for managing external vendor data and reducing study timelines.
Erin's first-hand knowledge of the problems external data can present and the continued collaboration of a top 10 pharma company have driven Data Exchange, P21’s new non-CRF data management tool, to become the first truly impactful solution to address these problems head-on.
Aligning Nomenclature
What’s the right way to refer to this type of data?
External vendor data
External lab data
Non-zero data
Non-EDC fata
Third party vendor data
There is no real "right" answer for this question. In this industry, we call external vendor data by different names, whether it’s because it’s how your individual organization chooses to phrase things, the training we had prior to entering the workforce or in previous roles, or just personal preferences. Throughout Erin’s presentation, she used many of those terms interchangeably because they all basically mean the same thing – any data collected outside of electronic data capture.
External Data Life Cycle
Everything in the external data lifecycle essentially starts with data collection. Whether this refers to a sample from a subject, a bio specimen, blood sample biopsy or even digital data – it all starts with the subject, and it all needs to be collected before moving to the next phase of the life cycle.
Once the data is collected, it is handed off to the Sponsor or CRO to manage it from there. It is analyzed and interpreted, then transformed and validated to ensure it is compliant with your expectations and requirements.
Next, the data is aggregated, combined with everything else in your trial, and converted to SDTM. Many of our P21 Live attendees have been heavily involved in this part of the data lifecycle, as well as the analysis and statistical assessment.
The last step is where P21 has historically entered the equation, when you prepare to report to the regulatory agencies. As you know, P21’s Enterprise solution helps ensure data compliance with specifications and that the validation works for CDISC requirements.
Now, we’re taking that same foundation and applying it upstream, where we’ve recognized a huge – and growing – pain point: the handoff between the generation and acquisition of external data. There are so many manual steps right now in one of the most critical areas of the data life cycle, and we are confident that we’ve created a tool that will address and streamline this process for our users.
Think about it like this:
How long does it take to get a vendor to send data to you?
How long does it take you to create a specific patient and tell them what you want?
How often is the data you receive in good SDTM format so you can analyze it?
Everything our P21 team is doing is to achieve a reduced timeline, and the better we can manage the data upstream, the easier and more efficient the jobs later in the data life cycle become.
Let’s take a look at the current state and where we are going:
Where Data Originates Now
Did you know that more than 70% of data is now captured outside of the EDC? And that number continues to grow as we see the emergence of things like decentralized trials, which are amazing and very exciting.
Most studies have at least four - and often more - external vendor data sources. This has a huge impact on end-of-study timelines, which have increased over the last several years by 32%, and many of you are one of the last steps in this pipeline.
You’re feeling the pressure to get that data in faster and faster, but the top cause cited for delays right now is... (drum roll, please) external vendor data.
Best Practices for External Data Management
P21 has done a series of informational webinars on external data management best practices, and Erin reviewed a few that will help reduce some of the frustrating obstacles in end-of-study timelines:
Specialization of resources – create a vendor team. The data is growing faster than the infrastructure we have to support it, so having either one vendor team that has multiple specialties throughout the data lifecycle (data management, data acquisition, data standards, etc.) who understand this really well, or create sub teams for each of those groups.
Adopt and enforce non-CRF data collection standards – We have data collection standards for CRFs and we have rigid standards for how the data needs to appear in its final form, but there are no standards that tell us the best way to collect all this data.
Set clear guidance and protocol for vendor data – Have you ever seen a protocol that contained “biomarkers may contain but are not limited to...?” Without clear, acceptable limits and guidance, you could collect just about anything you want and record it in any format.
Pro tip: Have your specialized vendor team review the protocol for any red flags and use their feedback to drive decisions that make things simpler downstream.
Leverage vendor team expertise for contracts and procurements – you should always be evaluating your vendors to be sure they are using validated, compliant systems, but this review should be a little more robust than that. People involved with contracts and procurement aren’t typically familiar with the lab flow process, so they aren’t able to provide enough objective information for you to determine whether a vendor’s processes make sense, whether it may be advisable to change vendors, or whether you might need to build a tool to safeguard against other inefficient practices.
Good study specs are probably the most critical building block – Have a place to create specs that can be used and reused, where the rules are very clear, everyone understands them, and there’s a forum to collaborate on them.
Establish data validation checks – checking for conformance at multiple points in the right place and in the right part of the data flow is essential. Checking as the data is uploaded so that a vendor knows whether it meets requirements for structure and format, checks done for reconciliation by a management team, and checks for value and content by an analysis team are all crucial to reducing your timeline and creating efficiency.
Create an auditable and traceable data validation workflow – identifying and understanding who did what and when is important to keeping your team informed and always working in the same direction.
Measure what matters – When all the pieces of the external vendor data life cycle live in different systems, there’s no real way to capture good metrics across the entire flow. Having objective metrics in the form of established key performance indicators (KPIs) means knowing how good a vendor is with regard to data quality and delivery timelines, and it also means no more manually entering information into spreadsheets to roll up into dashboards for leadership.
How P21 Data Exchange Meets External Data Management Needs
Specification Management – The ability to create, edit, update, revert, and duplicate specs directly in the app, validate them to ensure they make sense, and collaborate in real time so that everyone on your team can see the single source of true specification means improved efficiency, communication, and organization. No more excel spreadsheets that get emailed to the study team for comments and changes in an endless, confusing thread before being emailed to vendors!
Data Delivery – Create a single place where data is delivered for all your vendor files and manage access to that data delivery location in one location. With Data Exchange, of course you can still use Aspera to upload, but now you have other options: https, CSV, SAS datasets, Excel files, whatever it is that a vendor is sending to you. And as of version 5.3, you can accept SFTP files as well.
Data Validation – When a vendor uploads a file, it is validated immediately, and they (and you) can see the results instantly. Receive clear and actionable outputs within our issue management system. Ensure your vendor data conforms to your specification.
Query Management - A vendor uploads a file, and they can understand and address some of the issues. But what about the issues where you’re not sure? With DX’s issue management tools, you can collaborate with your entire team about an issue, whether it is data management, data standards, or even the external vendor team. Pose questions to the group about whether they’ve encountered a similar issue previously and how they’ve addressed it. Track communication about the issue all in one place.
Quality Metrics - Everything is tracked in our system, from when the spec was created to when it was finalized, how long it took you to get a file from a specific vendor, how good the data is in a file, and more. Roll up the information into dashboards that provide a high-level overview for upper management or drill down to look across therapeutic areas, projects, studies, and vendors – all within the app.
Intuitive User Interface - Every user that logs in will enjoy the easy-to-use interface that our P21 customers have come to know (and love), but each user will also only see information that is relevant to them, their assignments, and their access.
Sample Data Generator - You’ve created a flawless specification and you’re ready to start validating data. Simply click Export Sample Data to generate a simple data file that is compliant with your spec and provide it to your vendors so they can visualize and understand what you’re asking of them. You can also give this file to your data management team to create listings and their checks, and it can be used for pre-programming if you’re not getting anything until the very last second on a Study.
Spec Chat Collaboration Tool – Vendors have read-only access to your specification and cannot make any changes. So, what happens if they have a question about the spec? This tool allows your whole team to communicate – even external vendors – directly in the specification UI. Comments and questions live in-cell and are stored in one place. At the end of a study, simply export your Spec Chat log instead of combing through and archiving endless emails.
Why Use Data Exchange?
Pinnacle 21 Data Exchange currently has all the features discussed above, all in one place, and all ready for you to start using TODAY.
With P21 DX, you’ll be able to:
Reduce timelines
Reduce resources and effort needed
Reduce the number of systems you’re supporting (STPs, different portals for vendor delivery, communication tools)
Looking for more information on Data Exchange? Contact your Customer Success Manager to schedule time to take a deeper look into how DX works and how you can leverage this intuitive integration into your workflow.
