Tenvia for Sponsors
Keep oversight of
every protocol decision.
Move towards your next study commitment knowing which questions are resolved and which still need attention. Explore how your internal team and CRO partners can examine evidence and trade-offs together, with Sponsor authority at the centre.
From design question to a clear decision
Does this test, procedure or questionnaire belong
in the study?
Examine why it is needed, which objective or endpoint it supports, what evidence supports it and what it asks of participants and sites.
- 01
State the purpose.
Connect the test, procedure or questionnaire to the objective or endpoint it is intended to support.
- 02
Review the evidence and assumptions.
Keep the relevant sources, planning assumptions and unanswered questions visible.
- 03
Ask the responsible specialists.
The accountable clinical, operational, statistical, data and regulatory professionals decide what belongs in the protocol.
Working with your CRO
Keep ownership clear across organisations.
Who owns the study and its records?
Name the study owner and workspace administrator. Agree who owns the protocol, contributed material and decision records, how long they are kept and how they will be returned. The agreement defines these responsibilities; workspace access does not transfer ownership.
Does each CRO colleague need a separate purchase?
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 do we preserve Sponsor oversight?
Define which colleagues contribute, which specialists review and who can authorise a protocol version. CRO recommendations remain distinguishable from Sponsor decisions.
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.
From review to release
Your protocol. Your release decision.
Use Protocol Ready to understand the outstanding checks and responsible reviewers in the intended workflow. An authorised Sponsor person releases the exact version. The intended handover combines Word and PDF documents with the Protocol Intelligence Record.
Explore readiness and Sponsor release →Protocol development across functions
See the questions each function needs to answer.
Bring the decisions requiring each function’s expertise to them. Clinical teams examine purpose; Operations, investigators and site coordinators examine visit and screening feasibility; patient/public perspectives can raise design burden concerns. Statistics and Data Management examine measurement and collection implications. Preserve each concern and Sponsor response against the exact version.
Explore review across the teamScientific, site and participant perspectives.
Team responsibilities · Review product scope
Clinical Development
- The challenge
- The reason for a test or procedure can become separated from the study objective.
- The Tenvia approach
- Develop the objectives and endpoints with the team, and record the scientific reason and evidence for each proposed test or procedure.
- Why it matters
- A clear explanation of why each item belongs in the protocol.
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.
Patient, carer and public reviewers
- The challenge
- The protocol can describe procedures without showing the work they create for a participant.
- The Tenvia approach
- Present approved design information in plain language and ask about visit time, procedures and accessibility. Record whether the team adopted the feedback and why.
- Why it matters
- Design burden can be discussed without collecting personal medical histories; qualified privacy and access arrangements precede external invitations.
COO and programme leaders
- The challenge
- Unclear handoffs make it difficult to know who must act before a version can move forward.
- The Tenvia approach
- Follow the sequence of contributions, review questions, approvals and version handoffs.
- Why it matters
- Visible responsibilities and unresolved work, without treating a completed task as approval of the study.
Explore with your team
What would help your team commit with greater confidence?
Bring one unresolved study question. Use a sample to explore a clearer path from evidence and expert concerns to an informed decision.