CRO Selection, Management & Operational Governance
The right CRO partner. The right operating model. From the start.

Selecting a CRO is one of the most consequential decisions a biotech or emerging biopharma company makes, and it is almost always made without the operational expertise needed to do it well. Proposal language is evaluated at face value. Capabilities presentations go unchallenged. Governance expectations are left undefined until a problem forces the conversation.

ABRA Clinical Consulting changes that dynamic entirely.

Angela Brady brings more than 28 years of experience on both sides of the CRO relationship, as a senior operational leader inside global CROs, and as a principal advisor to sponsors who need to select, structure, and manage those relationships with confidence. This service is built for biotech and emerging biopharma companies that have compelling science and limited internal clinical operations infrastructure and need a seasoned expert in their corner from the first RFP through final study close.

What this engagement covers:

• CRO Selection & Due Diligence — Defining the right CRO profile for your program, therapeutic area, and operational needs; building the evaluation criteria that go beyond capability presentations and reference calls

• RFP Development — Writing fit-for-purpose Request for Proposal documents that ask the questions CROs would prefer you not ask, covering governance expectations, team continuity commitments, escalation protocols, quality oversight, and performance accountability

• RFP Process Management — Running the full proposal process from issuance through finalist selection, including bidder conference facilitation, proposal scoring, clarification question management, and final recommendation

• Contract & Scope Governance — Translating your selected CRO's proposal into a contract structure and scope of work that creates real accountability

• Operational Model Design — Building the governance frameworks, oversight charters, and escalation pathways that define how your organization and your CRO will work together from day one, aligned to ICH E6(R3) standards

• Ongoing CRO Oversight & Performance Management — Providing the sponsor-side operational leadership to hold your CRO accountable to the standards established at contract, including metric review, issue escalation, and relationship management at the senior level

• Inspection and audit readiness support — Ensuring your oversight documentation, vendor management records, and governance infrastructure are audit-ready at every stage

Who this is for:

This service is built for biotech and emerging biopharma companies navigating the CRO relationship for the first time (or rebuilding it when your trust is limited). If your organization has compelling science but limited internal clinical operations infrastructure, ABRA provides the expertise to select the right CRO partner, structure the relationship for accountability, and ensure that your program is never at the bottom of a large CRO's priority list.

This includes early-stage biotechs preparing to outsource their first Phase I or II study and needing a seasoned operational voice to evaluate CRO proposals, negotiate contracts, and establish governance from day one. It is equally well-suited for growth-stage biopharma companies that have an existing CRO relationship but lack the internal bandwidth to provide meaningful oversight and are beginning to see the consequences in timeline slippage, communication gaps, or quality findings.

ABRA serves as your executive clinical operations function when you do not yet have one, and as a senior check on your CRO's performance when you do.

Engagement model:

Available as a defined-scope project for the selection and RFP phase, a retainer for ongoing CRO oversight, or an end-to-end engagement covering both. Every component is led personally by Angela.

Your CRO works for you. ABRA makes sure it stays that way.