Audits & Evaluations

Kestrel knows the importance of ensuring good data management-related processes and documentation. We perform audits and evaluations to assess the robustness of a potential outsourcing partner, prepare an organization for a regulatory audit, or identify where processes could be improved.

Whether the client is a pharma company expecting a pre-NDA agency visit, an academic research center interested in partnering with pharma companies, or a company setting up a new data management department, Kestrel has the tools to identify potential trouble spots and fix them promptly.

Audits

Kestrel’s audits are assessment of an organization’s data management-related processes and documentation that focus on determining the degree of compliance with regulations.

Audits tend to be fairly narrow in scope, and result in a report that outlines the organization’s primary regulatory vulnerabilities without necessarily offering remedies. These are useful, for example, for determining if a potential CRO partner is a good choice.

Evaluations

Evaluations are much broader in scope, and are designed to help an organization identify and fix areas of possible vulnerability. They look beyond the regulations and assess the organization’s processes and documentation with respect to industry best practices, guidelines, and similar materials.

Evaluations are designed to help an organization improve, rather than point out its flaws. The results of evaluations remain in the client company, and they can decide what, if any, findings should result in changes.

Evaluations are particularly useful for new data management organizations looking for confirmation of their decisions, established departments who wish to check for possible blind spots, and academic research organizations interested in conducting submission-quality studies.