RESPONSIBILITY MATRIX SERVICES
BioBoston CRO provides clinical trial responsibility matrix support for sponsors that need clear, documented accountability across sponsor functions, CROs, sites, laboratories, technology providers, and specialist vendors. Support can include a Sponsor-CRO responsibility matrix, RACI model, transfer-of-obligation alignment, process-level ownership map, governance and escalation model, or remediation of conflicting contracts and plans.
Global Reach
Therapeutic Area Coverage
Years of Experience
START A CONVERSATION
Select the support you need and share a few details about your project. We’ll use this information to route your inquiry to the appropriate BioBoston team member.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
The engagement should be scoped around the current state of the work, the intended decision or milestone, the source package, and the sponsor's approval responsibilities.
Define process-level responsibilities, decision rights, reviews, approvals, evidence, handoffs, and escalation before work begins.
Reconcile statements of work, transfer records, plans, procedures, governance, systems, and actual practice into one approved operating view.
Clarify who owns actions, decisions, records, systems, vendors, quality events, changes, closeout, and sponsor oversight.
when needed
Problems
The service is most valuable when the team can identify the specific control gap, decision, deliverable, or
recovery need rather than requesting generic capacity.
Scope
The exact scope depends on the maturity of the work, the quality of the inputs, the sponsor’s procedures,
the review model, and the target milestone.
Deliverables
Deliverables should be confirmed at kickoff and linked to defined sponsor decisions, review cycles, and downstream handoffs.
Client inputs
The sponsor does not need every detail finalized before kickoff, but approved decisions, open questions, source owners, reviewers, and deadlines must be distinguishable.
Process
1. Confirm the purpose, current state, intended use, milestone, stakeholders, responsibilities, systems or vendors, and agreed deliverables.
2. Review available source materials, prior decisions, procedures, evidence, and open issues; issue a focused gap and dependency list.
3. Develop the work plan, specifications, document, assessment, or control package included in scope.
4. Coordinate review through named sponsor and cross-functional decision owners and maintain a controlled open-item and comment process.
5. Perform the agreed technical, quality, consistency, or operational checks and document remaining risks or limitations.
6. Prepare the approved handoff, implementation, submission, remediation, archive, or next-step package as defined in scope.
Considerations
The work should remain proportionate to the risk and intended use, follow the sponsor’s controlled process, and preserve clear sponsor decision authority.
Engagement options
BioBoston leads the defined scope from assessment and planning through drafting or execution, review, quality control, and handoff.
BioBoston addresses a specific section, decision, backlog, finding, vendor issue, or stalled deliverable without expanding the engagement unnecessarily.
BioBoston provides an objective second-line review, oversight role, or embedded specialist while the sponsor or another vendor retains primary execution.
RELATED SERVICES
Use the responsibility model to define how delegated activities are reviewed, verified, evidenced, and escalated by the sponsor.
Translate responsibilities into deliverables, metrics, meetings, decisions, issue management, and operational accountability.
Provide an embedded PM to operate the agreed responsibilities, handoffs, decisions, and governance.
Clarify document, evidence, review, approval, publishing, and application-preparation responsibilities across functions and vendors.
Expertise
Responsibility-matrix facilitation should match the study phase, vendor and contract model, number of functions and systems, regulatory transfer requirements, governance complexity, and current ownership conflicts.
RESOURCES
Explore the following resources for additional insights and information relevant to this service.
A planned template for process, task, deliverable, responsible, accountable, consulted, informed, review, approval, system, evidence, and escalation.
A planned checklist for scope, definitions, contracts, processes, decisions, handoffs, systems, records, exceptions, review, and change control.
A planned explanation of operational role mapping, contractual delegation, regulatory transfer records, and continuing sponsor accountability.
FAQs
It is a controlled map of who performs, is accountable for, reviews, approves, is consulted on, is informed about, escalates, and retains evidence for defined clinical trial processes and deliverables.
No. A RACI clarifies operational roles and decision rights. Regulatory and contractual transfers require appropriate agreements and records and do not remove continuing sponsor oversight responsibilities.
Yes. A draft matrix can support requests for proposal, bid defense, scope comparison, contract negotiation, governance design, and identification of sponsor-retained responsibilities.
Yes. Review can compare contracts, amendments, transfer records, plans, procedures, systems, records,
governance, and actual practice and identify discrepancies requiring sponsor decisions.
It should be detailed enough to prevent material gaps and duplication without becoming unusable. Higher risk decisions, interfaces, systems, evidence, and exceptions generally need more specificity.
No. It clarifies roles and may reflect documented delegation, but sponsor accountability and oversight obligations remain governed by applicable requirements and agreements.
PROJECT FORM
Share the study, sponsor and vendor structure, contracts, current matrix, recurring ownership conflicts, systems, and target milestone. A BioBoston team member will review the request and follow up regarding fit and possible next steps.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
A productive first discussion identifies the study, parties, contracts, processes, systems, decisions,records, recurring gaps, and next milestone. BioBoston can then define the RACI, responsibility, decision
rights, or reconciliation scope.
