Everyone agrees 100% that QUALITY makes a difference and is paramount in the clinical trial industry! Intent and ethics are also critical, and these traits can really shine if you find the right CRO.
Recently, Linical has been asked to rescue a growing number of projects. Why? CRO project team turnover, data quality and integrity, non-compliance in regulatory, critical missed deadlines, surprise change orders, lack of executive oversight, or misalignment with Sponsor goals.
What are the warning signs that your clinical trial may be in trouble?
- “Bait and switch” --- not the same project team as you hired
- High team turnover
- Mismanagement of timelines or budget
- Lack of transparency and poor communication --- this takes time to build with new Sponsor / CRO relationships
- Unethical behavior or lost passion
- Limited executive oversight and engagement
- Quality issues including monitoring, data, and/or safety
- Poor investigative site engagement and relationships --- they are so critical in a clinical trial
- Not having solutions for obstacles and problems, including risk mitigation
Both large and small projects are pivotal to the “big picture” and ultimately improving patients’ wellbeing in the clinical trial industry. Recently, we’re hearing many Sponsors have lost faith in some CROs, and while this is not new in the industry, it appears to be a growing trend. Because we develop therapies for patients, we all must care about quality and take key steps to protect data integrity and the wellbeing of patients across the globe.
When projects run smoothly, there is a clear captain of the ship with known tasks and responsibilities. During a “rescue” situation, the captain is the last person to abandon ship and is the key leader in steering the ship to safety. People are no longer confined by the boundaries of their position, grade, or official status. You may become the leader of an emergency “rescue” team, meaning we all must all work together to change a situation or the project course.
Ultimately, when a hard decision is made, regardless of the trigger, to transfer a project by the Sponsor to another CRO, there must be critical thinking and collaboration between all parties. A rescue can be full-scale or it can apply to a single, troubled service area. When “WE” embark upon rescuing a clinical trial, a paradigm shift is the most critical point to accept, define, and embrace. The complexity of any “rescue” situation requires a discovery phase, a detailed transition plan, and communication documents to ensure the seamless hand-off of specific duties between vendors and the Sponsor.
Additionally, it is critical to make sure that the Sponsor and the new CRO have:
- Created a risk roadmap outlining possible reasons for transition and what steps the CRO would take to mitigate risk
- Clearly outlined the transition period and timing by outlining criteria for key deliverables and expectations
- Embraced that the new CRO is not “punished” for the mistakes of others---it is ultimately a partnership. Trusting relationships are nurtured over time.
Other key areas to watch and ask questions about your rescue CRO partner are:
- Operationally: How will the transition affect your business operations?
- Reputationally: Will sites/patients be affected by a transition?
- Legally: What quality and “out clause” language is in the contract?
- Compliance: Are all regulatory and compliance rules/infrastructure in place with the new CRO? What is their audit trail?
- Financially: Are they financially sound and publicly traded?
Being confronted with a failed project is frustrating and daunting, but it may become your greatest success story, depending on how you handle the situation. No matter your reason, Linical has built a strong CRO reputation of quality and care for our clients, the sites, and their patients. Patient engagement is critical in today’s trials, so hire a CRO that cares about your patients and your end result.
If in doubt, a good seasoned CRO professional can even act as an additional set of eyes, or a “sounding board,” to help you gauge if you are ready to make a change. Your new CRO partner should LOVE this industry as much as you do, embracing innovation and change, while ensuring quality stays at the forefront of your clinical trial.
Author:
Clareece West
Chief Commercial Officer - Linical