Determine Overall CRO Characteristics
Rare disease research requires a more collaborative and attentive mindset of all participating stakeholders, including the CRO you choose to implement a clinical study.
The characteristics — or corporate personality — of your research partners can often be the single factor in meeting study timelines and budgets vs costly overruns and extended study durations. As sponsor, once you set the parameters and identify a few CROs that meet your basic requirements, you should strongly consider those CROs who possess certain characteristics, such as:
- Values And Recognizes The Importance Of Team Chemistry And Works Decisively To Foster Team Cohesion And Unity At All Levels Of The Study Team
- Understands The Importance Of Being A Strategic Partner Rather Than Simply An Implementor
A group that brings solutions to the challenges of rare disease research and engages the
sponsor in open discussions is instrumental to finding the best solution to the challenge at hand. As discussed above, a CRO with extensive rare disease experience and experts on staff can bring to bear the learnings of other rare disease trials for your study’s benefit.
- Recognizes That The Sponsor Is The Expert And Key Driver Of The Clinical Trial And Works To Enhance Their Disease Specific Knowledge With Their Prior Rare Disease Study Experiences
- Is Cost Conscious, Fiscally Responsible And Considerate Of Budgets, Yet Understands And Clearly Communicates How Additional Activities Can Add Value And Reduce Time To Market
- Provides Flexible And Transparent Contracts & Budgets, Ensures The Sponsor Understands What They Are Paying For And Is Clear In Communicating Project Assumptions & The Change Order Process, Including What Might Trigger A Change Order
- Understands The Importance Of Timelines And Achieving Enrollment Goals
- Is CRA-centric And With A CRA Turnover Rate Lower Than The Industry Average
A low turnover rate yields better trial consistency and continuity of study learnings.
To this last point, the CRA should be viewed as a critical component to any contract research organization. They should not only be empowered, but also encouraged to make decisions and offer solutions that could possibly have a positive impact on a clinical trial. Therefore, the CRA characteristics/requirements you should be looking for include:
- An innate sense of intellectual curiosity and active participant in the research process.
- Willingness to be flexible, collaborative and adaptive
- Creative problem-solving capabilities (coming up with solutions to difficult problems)