Things to Consider When Selecting a CRO
Evaluating a Contract Research Organization (CRO) for your clinical project may seem like a daunting task. You may begin with the internal assessment of the research project(s) to determine which activities may be done in-house and which will be outsourced. Then, there is the need to identify a manageable number of appropriately experienced CROs to request proposals. Finally, CRO capabilities and proposals must be compared to assess the most appropriate partner for your project. CRO options range from large, publicly owned companies with comprehensive services and global coverage to privately-owned niche providers with specialized services. CRO services and budgets often vary significantly with respect to details and assumptions, which makes comparisons difficult. And, the CRO employees you talk with or meet may not be the ones assigned to your project. To facilitate an efficient, effective evaluation of CROs, Promedica International (PMI) has compiled the following suggestions for your consideration. Services Provided It seems obvious that you would only consider CROs offering the services you need. However, don’t accept things at face value – check to confirm mutual understanding of the activities included in each service, as well as any applicable geographical considerations. Check, also, if the CRO’s services are all provided by CRO employees/subsidiaries, or via alliances with niche service providers – having everything “under one roof” may facilitate project management, but niche service providers often outperform a large CRO in their designated area of expertise. You might also ask for and consider the CRO’s suggestions regarding services that may facilitate more efficient completion of your project. Related Experience – Similar Projects Related project experience at the CRO often translates into program efficiencies for you – in procedures, work templates, resource networking, and team training. If the CRO does not have directly related project experience, you might ask for metrics regarding other projects that may be similar in terms of trial design, subject demographics, and medical practice patterns. Related Experience – Similar Clients Sponsor companies have a variety of organizational cultures and structures. Early stage companies often have a singular focus on the status of their trial and the need to know details regarding trial activities at any given time – they typically want a fast response and creative problem-solving. Established companies may delegate the trial and request only periodic status reports – they may place a higher priority on procedural rigor than speedy response. What is your company’s culture? Does this CRO have experience working with companies similar to yours?
Financial Stability The CRO business involves significant business risk; e.g., regulatory approvals may be delayed, products may not be sufficiently efficacious to proceed to the next study phase, and sponsors sometimes change business strategies that may result in project cancellations. You want to feel comfortable that the CRO is financially strong enough to withstand business downturns while providing appropriate attention to your project. How long has the CRO been in business? Is their project portfolio sufficiently diversified to mitigate the risks described above? What practices does the CRO utilize to facilitate sound cash flow management? Employee Training, Experience, and Stability What are the educational and professional backgrounds of the CRO’s employees? Do they have sufficient experience and training in Good Clinical Practice to perform assigned project tasks effectively? Also, project team turnover generates additional expense and inefficiency. What metrics can the CRO provide regarding employee retention? Delivery of Services “How does a project get to be a year behind schedule? – One day at a time.”1 Take time to understand how the CRO delivers their services and evaluate how their systems will integrate into those of your company. Who at the CRO is responsible for managing the project schedule and budget? Who supervises the project team? Who at the CRO is ultimately responsible for your project? Did you have a chance to meet and talk with the key person(s) who would be working on your project? Generally, a single point of contact facilitates clearer communication. How detailed is the project budget provided by the CRO? Did they take sufficient time to review the budget so that you can verify concurrence of assumptions and general plans? How often does the CRO invoice and how well does the invoice format match the budget provided? What sort of budget reports can the CRO provide? What is the CRO’s typical format for reporting and monitoring on the project schedule? Does the CRO have a comprehensive checklist of tasks required for clinical trials? 1Fred Brooks, Software Engineer and Author Track Record – Budget/Schedule Because of the uncertainties associated with conducting human clinical trials, many project budgets and schedules may be revised once or more after project initiation. How does the CRO handle this? Are they proactive in identifying and addressing deviations? You may want to get the names of client references you can talk with to get additional data about the CRO’s performance this area. Track Record - Client Satisfaction Client satisfaction is important data for evaluation of the CRO’s performance; however, be careful not to base your entire assessment on feedback from only one client. Does the CRO have a formal method for monitoring client satisfaction across projects? If so, how often is this assessed and what metrics can the CRO provide? Again, you may want to get the names of client references you can talk with to get additional feedback about their experience working with this CRO. C:\Documents and Settings\ZEEWEB\Local Settings\Temporary Internet Files\OLKAB\SELECTING A CRO.doc Page 3 Infrastructure Appropriate CRO infrastructure is essential to support your project requirements. Does the CRO have adequate facilities and staff to handle your project requirements? What software is used to track project performance? How is the clinical information system organized? - Is clinical data maintained in accordance with 21 CFR Part 11? What steps must be taken to export data maintained at the CRO into your company’s system? What mechanism does the CRO provide to facilitate sponsor review of clinical study data? How does the CRO manage essential study documentation? Quality Assurance Quality assurance is essential to good clinical research practices. Decisions regarding product safety and efficacy are based on the assumption of study integrity. What methods does the CRO use to implement their services and confirm the quality of their work? What experience does the CRO have with FDA or other applicable regulatory authorities? Have they been audited by any of these authorities? If so, what was the result? If observations were noted, what has the CRO done to address these observations? Does the CRO have any additional quality assurance credentials; e.g., ISO certification?