In the scenario where we have a company is only performing our literature searches and providing listings of the articles found on a weekly basis (as per our company SOP) and they are not actually assessing the articles for AEs, what kind of contract or agreement should be put in place for this type of vendor?
Would this vendor need to be Audited fully or would a QA assessment questionnaire suffice (due diligence)?
Thank for the feedback in advance.
Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.
If the contracted company is merely performing the search on the relevant databases using a keyword search written by the sponsor company and is not looking at the output from the search for example; merely forwarding the hits to the sponsor to review, then a simple contract should be sufficient allowing for obligations to be in the form of a Master Services Agreement complete with schedule of tasks to be performed. (a MSA with task list?)
However, if the scope of activities expands in areas such as; company is involved in reviewing the data in order to determine whether the listings contain information relevant for your company, or whether the reports contain safety information (not necessarily containing AE information) or that they are generating the keyword search criteria to be used (and validating these), then an expectation would exist for the company to have a safety agreement in place which covers at a minimum, an adequate quality system in place.
For those companies that are merely performing a literature search and forwarding the output to the sponsor for further evaluation, such as the situation you have highlighted, an audit would be recommended in the form of a desktop based audit (Questionnaire).
If the company is performing more activities, then an audit may be warranted.
It is expected, as per GVP module I & IV for due diligence assessments to be performed, in order to provide assurances to PV and the sponsors management that the company is capable of performing the critical PV tasks and that systems are in place to ensure continued working in situations that business activities are affected.
Audits would generally be in addition to due diligence activities in order to demonstrate that a organisation is fulfilling the tasks as detailed within contractual arrangements.
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