Clinical Operations,
Vendor Oversight Planning,
& TMF Management

SWOT ClinOps Specialists will coordinate with your team to plan, implement, manage, execute and oversee the completion of clinical studies in accordance with applicable regulations and guidance, including ICH and GCP — all while keeping timelines and budget at the front of mind. We'll ensure all internal and external team members are communicating effectively in order to prioritize efficiency and clarity throughout a trial's duration.

Even when you've transferred responsibilities and obligations to a CRO, vendor oversight is still key. At the end of the day, the execution of a study and its results are owned by your company. Ensuring you have a Vendor Oversight Plan in place for accountability is vital, and SWOT's Vendor Oversight Planning team can help you create one that ensures you and your CRO meet each important milestone.

SWOT TMF Managers manage and oversee the development process for critical study documents, including protocols and amendments, IBs, ICFs, CRFs, and CSRs to ensure successful regulatory submissions. SWOT works closely with all involved functional areas to provide input on study-related documents and solve issues early and effectively so there are no surprises when it's time to submit to regulatory authorities.