By Penelope Przekop, MSQA, RQAP-GCP
A growing number of sponsors are challenged with selecting the right clinical research organizations (CROs). Unfortunately, whether you’ve chosen the right one isn’t always obvious until contracts are signed, patients are enrolled, and the documentation is flowing… or not. We need novel, practical, efficient approaches that account for our current reality. An intense industry focus on reducing redundancies, containing costs, and building efficiencies has propelled us forward on the science side. All of those are excellent goals, but the decisions to achieve them are often not properly weighing the risks involved. Cracks have formed in the foundational processes our industry designed to ensure compliance with the health authority regulations designed to maintain public safety.
The industry standard approach to CRO selection developed at the dawn of outsourcing. At a high level, the approach includes:
- obtaining requests for information (RFIs),
- obtaining bids and conducting bid defense meetings,
- conducting a vendor assessment, and
- executing contractual agreements.
In 2022, basic industry standard steps are being skipped left and right. The industry standard process for CRO selection results in several documents with overlapping information, including the RFI, bid, bid defense presentation materials, and a quality assurance (QA) assessment questionnaire or audit report. R&D professionals exploring CROs naturally focus on obtaining documentation most familiar to them, easiest to get, quickest to review, etc. Herein lies the disconnect. These documents, although potentially redundant, serve different purposes for different functions. It’s not as easy as one may think to simply choose one and rely on it to provide assurance that the CRO is capable of meeting operational and regulatory requirements.
Novel Strategies That Can Improve CRO Selection
Keeping the key steps above in mind, here are a few win-win suggestions and ideas to consider. By incorporating them into the vendor selection strategy, sponsors can avoid redundancies, create efficiencies, maintain a budget focus, and obtain real assurance that the selected CRO is an excellent choice on both the operational and regulatory compliance levels. When implementing any of these suggestions, documenting the process is critical. What the sponsor did to select, qualify, and engage the CRO must be clear to a regulatory inspector, even more so when taking novel approaches. This has always been the requirement, but now the criticality has skyrocketed due to the current pharma decentralized landscape.
- Rethink how you think about time. Slow down at the beginning to save time later. This is a huge industry ask. Building a culture of patience, delayed gratification, and growth mindset is golden. Additional time at the beginning could be needed for redefining your process; consistently following a process; adding a step that current staff aren’t familiar with, comfortable with, or even qualified to do; or pulling new skillsets into decision-making.
- Use the internet and your network for initial CRO research. There is now enough publicly available information to enable corporate and operational staff to vet potential CROs even before sending out an RFI. Take the time to do that and focus the subsequent activities and documentation on what you can’t determine from a website and what regulators require sponsors to document.
- Reimagine the RFI. Develop RFIs that not only include requests for corporate and operational information but also information required for an in-depth quality assurance assessment. Global regulators support vendor assessment methods based on risk. Due to this, sponsors often use a vendor QA assessment questionnaire in lieu of an audit. Combining the traditional RFI and the vendor QA assessment questionnaire will allow for a full, in-depth risk assessment at the start. This means that the sponsor’s QA leader and/or team must be involved early in the process. This may also call for stronger involvement from R&D initially if procurement staff are responsible for initial RFIs.
- Discover the hidden value of quality and compliance professionals. Involve a qualified QA professional at the start. To successfully implement #2 above, our industry must increase its respect for the value that pharma quality and compliance professionals bring to the table. It’s one of those professions that looks easy to a lot of people because they think they understand it when they don’t. This is quite dangerous in pharma these days. Numerous decisions that impact compliance in the short or long term are being made without input from QA and compliance experts. These are the individuals who can ensure that the right questions are in an initial, in-depth RFI, ensure that the process clearly reflects QA involvement, and ensure that the documentation is appropriate. They are also the individuals who can read the results and save the sponsor a lot of time, expense, headaches, sleepless nights, and more. They are trained to spot gaps, issues, red flags, etc., in ways operational staff are not. It takes a team that includes a quality and compliance expert.
- Use the reimagined RFI wisely. Your new RFI can be used to reduce redundancy and gain process efficiencies that save time and ensure compliance. If properly designed, the RFI document can support the following regulatory interests and requirements:
- Operational vendor selection
- QA risk assessment to determine vendor risk
- QA vendor assessment if that method is appropriate based on the documented risk assessment
- Reimagine the QA vendor assessment. CROs are usually high-risk vendors that require in-depth QA qualification audits. If QA has been involved in developing and evaluating the RFI just as they would a QA vendor assessment questionnaire, the vendor risk and qualification assessment will have begun even before you request a formal bid. Next, include QA in bid defense meetings. This can serve as another layer of QA vendor assessment, building it into the CRO selection process. Many of the topics ordinarily discussed during an audit will have already been discussed. This can reduce the audit agenda, streamline the audit focus, and improve the entire audit process. This layered approach to QA vendor assessment must then be described in the audit report.
Sign the contract after completing the activities above. This is a regulatory requirement. Across the industry, we’ve downplayed the importance of the prescribed order. Remember that our goal is not – and should not be – to avoid regulatory observations. It is to ensure data integrity and patient safety, while improving public health. Sponsors are spending more time and attention on contracts and getting started than on ensuring that they have selected the right CRO for the right reasons. Once the contract is ready to sign, and the initial operational planning is in motion, it’s human nature to view QA vendor qualification as a check-the-box afterthought. It becomes an activity easily tossed into the “do we really need all that?” category. Leaders convince themselves that the CRO is fine because it’s the largest in the industry, they used to work there, they used the CRO before, they know the CRO’s CEO, and the list goes on.
When outsourcing began, Big Pharma was hyper focused on finding out who these brave souls selling outsourced regulated services were, where they came from, and what made them qualified. Today, many people wonder who the brave souls creating yet another new pharma, biotech, or device company are, where they came from, and what makes them qualified. The tables have turned, and so must our mindset, priorities, and logic. The most novel approaches to CRO selection are rooted in reprioritizing how decisions are made in what context and order, and who is making them.
About The Author:
Penelope Przekop is a corporate quality management expert. Throughout her 30+ year career, she has worked with numerous Fortune 100 pharma companies, including Pfizer, Merck, Lilly, and Glaxo Smith Kline, and held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson. She is the founder and CEO of PDC Pharma Strategy and serves as the Chief Compliance Officer for Engrail Therapeutics. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Przekop earned a BS in biology from Louisiana State University and an MS in quality systems engineering from Kennesaw State University. She is a graduate of the Smith College Program for Women’s Leadership and the Rutgers University Senior Leadership Program for Professional Women. Her new book, 5-Star Career: Define and Build Yours Using the Science of Quality Management launches in November 2021 from Productivity Press.