sponsors
Scenarios that may look familiar
If you are a study sponsor, you might relate to one of the scenario’s described below. Please find out how we could be of service to you.
“As a sponsor, we are responsible for the overall compliance and oversight, and as such ensuring a proper contracting framework is an essential part of our strategy and planning. Involving a contracts specialist would help us to get better control over this aspect of the study conduct and save our study team valuable time.”
Smoother site contracting by an industry specialist
“In the industry, site contract negotiations are often considered a major delaying factor in the start-up process. Therefore, I would like to outsource this part of my clinical study to a specialist that I can easily integrate into my clinical study organization, in order to ensure an efficient contract management process whilst maintaining quality for risk management purposes.”
Strengthening our legal team for contract escalations
“We have contracted a CRO to perform contract management services, on the basis of an agreed framework. Modifications to certain parts of the site agreements shall be escalated to us, as the sponsor, for approval. However, whilst we have access to a good legal counsel, we do not have (sufficient) lawyers at our disposal with specialist knowledge and experience, and this may potentially lead to delays to our own clinical study. We would like to temporarily complete our legal team with specialist knowledge and resources in order to prevent this.”
Getting back on track
“We have contracted a CRO to perform contract management services, however, although the CRO is a specialist in the performance of the clinical process, the site contract management process may require some further support. Therefore, we would like to involve a specialist in this area, to constructively collaborate with stakeholders involved in order to get the process back on track.”
Occasional support and sparring on contracting topics
“We do not have extensive experience in handling the different contracts that are necessary for our clinical trial and it would be helpful if we could from time to time call an expert to discuss approach or ask specific questions in relation to the relevant contracts.”
Managing vendor performance
“Our vendors are valuable collaborators in the clinical study process. Setting clear terms and conditions from the very beginning helps all stakeholders to understand and properly manage expectations on deliverables, timelines and payments. It is known to us that this facilitates quality, progress and budget control. We could use specialist input to ensure our contracts are drafted to fully support these objectives.”
Legal review of study documents, such as a PICF
“When setting up our clinical trial in the different countries, we are responsible for providing or approving supporting study documents, such as letters of delegation or authorization, and patient informed consent forms. Although we are fully on top of the clinical and regulatory aspects of these documents, the legal and data privacy aspects still require specialist legal review.”
Expert support for consortium agreements
“Our organization will be involved in clinical trial conduct as part of a consortium this time. The contracting structure and requirements are different from what we are used to so far. We could use specialist legal support to ensure that arrangements are compliant with applicable regulations (for instance in the case of H2020 projects), the input and output of each consortium party is proportional, and a clear division of rights and responsibilities are established in the consortium agreement.”
Assistance with special contract types
“Given our current protocol, we require specific contract types, such as a licensing agreement and a material transfer agreement. Since we have not dealt with these type of contracts before, we would appreciate guidance from a legal specialist.”
Solving a dispute with our vendor
“Currently we are facing a critical situation with an important vendor that is to be resolved in a manner that will have minimal impact on the study progress. In our view, expectations and contract requirements were not fully met, and a proposal by vendor to resolve the situation did by far not address our concerns. We could use special assistance in clarifying how the service agreement with vendor 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) as a sponsor and controller of the personal data involved, we are expected to pay even more special attention to data privacy as part of our clinical study process. We encounter certain challenges, since the GDPR rules still leave room for interpretation and not all parties involved are used to the new requirements yet. We could use some guidance to align parties and ensure compliance.”