TECHNOLOGY & DATA MANAGEMENT access to CRO leadership.
• Subject matter experts (SMEs): Does the CRO have access to the SMEs your company needs? This can include functional experts, such as regulatory or medical writing, as well as therapeutic area experience.
To inform your decision-making process these distinct factors can be placed onto a grid that includes the weight or importance of each factor as it relates to your company. Each potential CRO partner should be rated on a consistent scale (e.g., scale of 1-10) for each dimension and that rating is then multiplied by the dimension’s weight to obtain an overall score. Risk analysis for each vendor should also be
performed. It may be appropriate to bias the risk analysis towards factors that may impact quality, as these are the dimensions that will receive the most scrutiny from regulators. Some factors to consider include: Quality of deliverables: Does the CRO have policies in place that assess the quality of deliverables and are those policies sufficiently robust? It is common for CROs to focus on turnaround time for metrics, such as report generation and delivery, as timely access to data is critical for ensuring patient safety. However, setting an arbitrarily aggressive timelines for the delivery of reports can lead to multiple failures to meet those timelines, which will need to be explained and documented. This may also introduce unforced errors in the reports themselves, as quality is sacrificed when speed is made a priority. Consistency of ownership and leadership: It
can be challenging to assess if a CRO is on the market to be acquired by a larger company, but it is relevant to consider the likelihood of a potential change in ownership and how that would affect the project team, standard operating procedures, and access to leadership which can introduce risks related to the quality of deliverables and staff turnover that need to be considered. Probability of turnover: Turnover rate of functional teams (i.e. project managers and CRAs) should be considered seperately from overall company turnover, which would include managers who may have risen in the company. Smaller CROs may not have the bandwidth to accurately track team turnover in a global way, but a de-identified sample study team list can be used as a proxy for this information. The sponsor should be aware, however, that the sample provided may represent a best-case scenario that was selected for its low turnover. Adjust your expectations accordingly. Overall history and stability of the CRO: How long has the company been doing business and how likely are they to continue to be a going concern? Will the CRO be able to provide support in the event of a future regulatory inspection? Taking a thoughtful and structured approach
to CRO selection provides a solid basis for a successful relationship with your vendor and increases the chances for an on time successful delivery of your project. Additionally, using this approach provides documentation that teams can use to provide justification for CRO selection as part of their vendor oversight management plans.
Figure 1: Sample CRO Evaluation grid. Score = Weight x CRO Rating Factor
Weight Cost Discount flexibility
Appropriate Study Phase capability Cultural fit
Regulatory Experience in Country X Therapeutic Area experience Total
38 | Outsourcing in Clinical Trials Handbook
6 7
10 5 2 8
CRO1 Rating CRO1 Score 3 5 6 9 2 3
18 35 60 45 4
24 186
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68
