By Penelope Przekop, MSQA, RQAP-GCP
Sponsor awareness of requirements for clinical research organization (CRO) oversight has grown. However, many are challenged with taking impactful actions based on issues such as high turnover, monitoring quality, adherence to timelines, and more. Sponsors have become more focused on ensuring that oversight documentation showing awareness is available during inspections, although issues persist throughout the study/clinical program.
CROs exist today because during the 1990s big pharmaceutical companies decided that outsourcing could potentially save money and shorten the drug development process. I’m not so sure improving quality and compliance was part of the initial lightbulb moment. These companies knew how to successfully develop and execute clinical trials. They were confident that outsourcing some of the entry level, less complex activities was a great move.
Fast forward to now: many (not all) sponsor leaders don’t know how to do what they need their CRO to execute on their behalf, which is often 90% of the activities. The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough.
Sponsors must be willing to make hard decisions. When it comes to CRO oversight, this requires a bit more intestinal fortitude than the current industry standard. Too many sponsors seem to be forgetting that they are the customer, one that’s paying a heavy price for services that can ultimately make or break them. Years ago, CROs knew that the sponsors could make or break their business; today, they know that many sponsors are lost without them. There’s something wrong with this picture. Following are three familiar areas where gutsy sponsors can make a start toward resetting the industry balance.
1. Hold Your CRO Accountable to Contractual Agreements
CROs want your business! Before you give it to them, be crystal clear about your quality and compliance expectations. The financial incentives I commonly see in sponsor/CRO agreements relate to timelines around clinical site and patient recruitment. Your CRO will absolutely want to recruit efficiently and quickly. They’ll receive a financial reward, finish sooner, and move on to the next contract. Whether intentional or not, quality and compliance are the first sacrificed to achieve speed. Pay CROs for their core services, which are always of high quality and compliant, according to every CRO capabilities deck I’ve seen, which is a tremendous number.
You are the customer. Hold your CRO accountable to deliver their services with the level of quality and compliance required by regulatory health authorities as well as by your company. Rather than giving incentives, have the hardihood to base CRO payments on their ability to provide what they agreed to provide. Change your mindset. Remember that quality and compliance are multifaceted. They include successfully mitigating and remediating issues in a timely manner. It’s also about not continuing to make the same mistakes, missteps, and oversights. It’s not always okay because there’s a note to file or a CAPA in place. As in life, problems are unavoidable. The refusal or inability to learn from them, ensure they’re not repeated, and/or accept responsibility requires bolder actions.
2. Include CRO Performance in Your Risk Management Strategy
Most sponsors rely on the CRO to manage risk at a study level. That’s good; however, sponsors should have a program-level risk management process that includes the performance of their vendors. Many sponsors are doing this; however, it’s time to kick it up a few notches by tying performance to action in new ways. It’s advisable to have a contingency plan in place should the CRO hit the threshold of what is deemed an acceptable performance.
I’m often puzzled by the willingness of sponsors to continue using (and paying) CROs that they outright consider unacceptable. Often the reason provided is it that “the issues do not impact patient safety and data integrity.” This assumption by operational professionals is yet another example of underestimating the value of quality and compliance professionals. Clinical research staff and management, many of whom have never been involved in a regulatory inspection, should not assume that recurrent CRO issues will not impact patient safety and data integrity or inspection outcomes; this is not their greatest area of expertise. The performance of your CRO is one of the, if not the greatest, potential risks a sponsor has to success, assuming the goal is weighted on the appropriate side of moral integrity in clinical research.
3. Accept that it’s Not Just About Escalation, it’s About Decision Making.
Most sponsors understand that establishing escalation paths is key to CRO oversight. Now it’s time to accept that the purpose of escalation is to ensure that the right people make the right decisions at the right times, including the toughest ones. Meeting minutes, emails, and other documentation showing awareness, requests, and even closure of issue after issue, again and again, are no longer enough.
Our industry has big CROs, with thousands of staff having various levels of experience. We also have more small, niche CROs than ever before. Many pharma professionals who began their careers when modern day pharma was beginning are nearing retirement. Global regulations require that staff are qualified to perform the roles and responsibilities assigned to them. Of course, everyone makes mistakes. I’ve certainly made my share. However, how many mistakes and issues can a CRO make before they drop off the qualified vendor list? It’s time that industry sponsors adopt more of a “three strikes, you’re out” mindset. No one wants to say “you’re out” these days. After all, doing so is an admission that perhaps the wrong CRO was selected at the start. Yet, if sponsors don’t begin to hold CROs to that level of accountability and have the hardihood to define and act after a predefined strike, our constantly morphing industry may veer into unsafe territory.
Global regulators, patients, and the public have legitimate expectations of sponsors and the leaders who hang out their shingles. All the little things that many feel “don’t impact patient safety, data integrity or inspection outcomes” are adding up across our industry. With all the balls sponsors are juggling, let’s make sure one of them has guts written on it.
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.