Tenvia for CROs
Bring delivery expertise
into protocol design.
Give sponsors a clearer basis for your delivery recommendations. Explore Tenvia’s collaborative approach to protocol development, connecting your expertise with evidence, practical assumptions and the decisions the Sponsor needs to make.
Bring delivery experience into the design
What does this schedule ask
of sites and participants?
Review the proposed visit schedule: when results must arrive, whether windows and departments can coordinate, and what staff, equipment or separate systems sites would need. Keep site variation, unknowns and the purpose of each procedure beside the design question.
Explore the protocol exampleWorking across Sponsor engagements
Make the working arrangement clear.
Can the CRO lead the work?
Agree whether the CRO buys the service or helps deliver the work. Name the workspace administrator and the Sponsor colleagues who will contribute or review. The agreement defines these responsibilities; workspace access does not transfer ownership.
Does every Sponsor need a separate subscription?
The proposal should list the organisations, users and studies included. Confirm whether external reviewers need a separate licence and whether any access limits apply.
How are multiple Sponsor studies handled?
Confirm who can access each Sponsor’s studies and what they can do. Check these controls during the supplier review. An agreement covering several studies does not allow data to be shared between Sponsors.
What goes back into our existing process?
Agree the protocol document, review record and version history needed by your writing, quality and regulatory teams. Confirm formats and handover responsibilities. Tenvia does not replace your EDC, eTMF or regulatory submission systems.
Shared authoring. Separate authority.
Make the handover easier to follow.
Plan writing assignments, specialist reviews, due dates and responses around the same protocol. Prepare a version-specific impact briefing for the site, data and vendor teams affected by an amendment. Acknowledgement, training and effective use require separate evidence; the Sponsor’s authorised person retains the release decision.
Explore the collaboration capabilities →Make your expertise easier to evaluate
Connect the recommendation
to the study it affects.
Bring relevant historical amendments, site workload and collection requirements into the design discussion. Keep each recommendation, concern, alternative and sponsor response with the exact protocol decision. Agreed access boundaries keep one Sponsor’s private history separate from another’s.
Explore review across the teamMake each contribution easier to review.
Team responsibilities · Review product scope
Clinical Operations and CRAs
- The challenge
- Visit instructions may look complete on paper while practical questions remain for sites.
- The Tenvia approach
- Bring site experience into protocol review. Discuss visit timing, procedure requirements and site capacity, and keep the response with the proposed design.
- Why it matters
- Focused review of patient time, samples, site workload and screening assumptions, with concerns and responses beside the decision.
Investigators and site coordinators
- The challenge
- A design choice may depend on local equipment, staffing, result turnaround or visits that a site cannot deliver as written.
- The Tenvia approach
- Ask a short, decision-specific question and keep each site concern, alternative and Sponsor response on the exact version. External participation requires qualified identity and scoped access.
- Why it matters
- Site-specific feasibility issues become visible during design. An investigator response does not approve the Sponsor protocol.
Medical Writing
- The challenge
- Comments and changes spread across sections, versions and email threads.
- The Tenvia approach
- Develop the draft with specialist contributors. Resolve their comments while keeping agreed wording, reasons and earlier versions together.
- Why it matters
- An easier way to resolve comments and check that sections agree.
CRO study and delivery teams
- The challenge
- Sponsors may receive a recommendation without the assumptions or delivery reasoning behind it.
- The Tenvia approach
- Develop the protocol with sponsor colleagues. Keep each recommendation, its evidence and the sponsor response with the relevant section.
- Why it matters
- An attributable recommendation, including historical changes and delivery concerns, that the Sponsor can examine and resolve. Responsibilities follow the agreed study arrangements.
Explore with your team
Bring a recommendation your Sponsor needs to understand.
In a working session, examine its evidence, assumptions and delivery implications, then identify the questions for Sponsor review.