Resolve the agreements that hold up study activation.

Who this is for

Sponsors, CROs, research institutions, sites, investigators, laboratories and vendors

Typically instructed by: Clinical operations · study start-up · site contracts and outsourcing · research contracts offices

Scope

What can be instructed

Clinical trial agreements

Sponsor-site, sponsor-institution and tripartite clinical trial agreements, including budget schedules and payment terms.

Sponsor and CRO agreements

Master services agreements, work orders, transfer of regulatory obligations and change-order mechanics.

Site, institution and investigator contracts

Research-institution contracts, site agreements, principal-investigator arrangements and sub-site structures.

Laboratory and vendor agreements

Central and local laboratory agreements, imaging, courier, IRT and other specialist vendor arrangements.

Data and material arrangements

Data-processing agreements, data-transfer arrangements and material transfer agreements for biological samples.

Risk allocation

Indemnity, insurance, publication, payment, termination and dispute provisions, and the escalation of disputed positions during start-up.

Before you instruct

What helps the firm assess the matter

• The parties to the agreement and any related entities, for the conflicts check.
• The protocol number or study identifier, and the sites or institutions involved.
• The template in use and whether it is the sponsor's, the institution's or a national template.
• The start-up deadline the programme is working to.