Rescue Studies 

If the issue involves data quality and deliverables, it is important for the sponsor to have complete data transparency with the rescuing CRO.

This means full visibility of reports and dashboards, along with up-front conversations to set expectations.

In turn, it is vital for the CRO to know the full history of the project. Some of the important factors to know when developing and creating a successful plan forward include:

• Various risks involved.
• Previous processes used.
• Decisions made to date.
• Sponsor perspectives.
• Central vendor information.
• Previous site information.

Collaboration and transparency from both sponsor and CRO will lead to comfort and rapport in the relationship.

A rescued project should be subject to a comprehensive gap analysis and clinical data review:

• The protocol is reconciled with the existing database. This confirms forms, edits, eCRF completion guidelines, skip logic, form rules, and ranges are accurate.
• Existing SOPs, processes, and tools utilized are reviewed. ARG addresses any major inconsistencies or concerns through an SOP deviation or updated plan.
• A plan is generated to re-establish trial expectations. A comprehensive review of the clinical data, coding, queries, external data vendors, and other key factors.
• Data Management (DM) leads meet with biostatisticians. ARG DM and biostatistics teams outline a path forward to produce compliant datasets.
• Biostatistics update. An assessment of the biostatistical work that has been completed, what can be retained, and what must be discarded.
• Communication of results. Once ARG’s gap analysis is complete, we share the full results with your team and present our plan for rescuing the study successfully.

It is compulsory to have experience understanding and running parallel operations when transitioning CROs. In a well-executed rescue, the new project team gets up and running while the other is temporarily maintained.

Our process continues as follows:

• Execute a copy of the previous CRO’s contract. Sites are often already up-and-running under contract with another CRO. In that case, we will create a carbon copy of the same agreement for our partnership.
• Request a URL Transfer to take over the DM oversight. We ask for full access to all study data collected to-date. This gives ARG visibility into all information in the database(s) for Data Management to move forward.
• Smoothly transition central lab vendors, if necessary. The key is to get the new vendor up and going while closing out the other. This is done by planning out the switch-over tasks and timelines with key team members.

By selecting a well-suited and experienced rescue CRO, a complete adoption of the study emerges in terms of both commitment of the team and quality of the deliverables.