cros
Scenarios that may look familiar
If you are a CRO, you might relate to one of the scenario’s described below. Please find out how we could be of service to you.
“From time to time I am confronted with a temporary increase of site contracts that need to be processed. We do not have the time to hire and train new staff to handle this temporary higher workload and would like to have access to flexible resources in the form of site contracting specialists. This way, we can avoid unnecessary delays on our clinical studies and maintain a solid performance towards our clients.”
Site contracting support on demand
“We are a small, but growing CRO, and from time to time we need support with processing site contracts for our clinical studies. At this stage, we would like to avoid hiring permanent resources, but it would be helpful if we could engage flexible resources in the form of site contracting specialists to take care of site contracting for us, including management of ancillary contracts such as lab and pharmacy agreements.”
Getting back on track
“We are encountering delays in the study start-up process, since the site contract management process is cumbersome. It would be helpful if we could contact a specialist to assist with identifying the bottlenecks and determine approach to get the process back on track on the short term, and maybe also to assist with the improvement of the applied processes moving forward, to avoid unnecessary delays on the longer term, and deliver in accordance with our client’s expectations.”
Managing vendor performance
“In support of our own services, or upon request of our clients, we are regularly contracting with different types of vendors. Setting clear terms and conditions from the very beginning to properly manage expectation on deliverables, timelines and payments, and ensure alignment with our obligations towards our clients. Every now and then we could use specialist input to ensure our contracts fully support these objectives”
Legal review of study documents, such as a PICF
“As part of our clinical trial services, we are sometimes responsible for drafting supporting study documents, such as letters of delegation or authorization, and patient informed consent forms. Although we are fully equipped to take care of the clinical and regulatory aspects of these documents, the legal and data privacy aspects still require specialist legal input and review, before we are sending the documents to our client for final approval.”
Assistance with special contract types
“For a current project, we are requested by our client to draft and negotiate specific contract types, such as a licensing agreement and a material transfer agreement. Since we have not dealt with these types of contracts before, we would appreciate guidance from a legal specialist.”
Solving a dispute with a client
“Currently we are facing a critical situation with an important client that is to be resolved in a manner that will have minimal impact on the client relationship and the study progress. Our client is not satisfied with the conduct of part of the services, and we proposed a reasonable solution, however, it was unfortunately not accepted. We could use specialist assistance in clarifying how the service agreement with client should be interpreted, so that we could better formulate our position and find a fair solution that – preferably – can get the collaboration back on track.”
Feeling confident about GDPR compliance
“Although already an important focus in our industry, since the implementation of the European General Data Protection Regulation (GDPR), we are expected to pay even more special attention to data privacy as part of our clinical study process. Our clients regularly request for guidance in respect of compliance requirements, interpretation of the GDPR and drafting or reviewing data processing agreements. In order to provide a reliable service to our clients, and provide them with the necessary support in this area, we could use some expert legal guidance.”