Clinical Trial Support

Clinical Research Organization Vetting and Selection:

The Capitol Biologics' Clinical team thoroughly assesses potential Contract Research Organizations (CROs) using objective, standardized processes. Criteria include the CRO's track record in similar therapeutic areas, regulatory compliance history, operational capacity, technological strengths, and quality management systems.

Qualification may involve reviewing past performance, client references, GxP compliance audits, data integrity systems, and the presence of experienced project teams.

Site audits or virtual assessments are commonly conducted by CDMO quality and technical leaders to verify the CRO's processes, risk management, and ability to meet sponsor requirements.

Participation in the CRO Bidding Process:

The Capitol Biologics' Clinical team assist clients in preparing detailed Requests For Proposals (RFPs), ensuring trial requirements are explicitly defined to enable fair, apples-to-apples comparisons among CROs.

They facilitate bid solicitation from a shortlist of pre-qualified CROs. Our project and quality experts often join the sponsor in reviewing bids, clarifying technical questions during the Q&A phase, and organizing bid defense meetings.

The proposals are evaluated using weighted scorecards that consider technical approach, budget, timelines, flexibility, and demonstrated partnership attitude—not just price.

Oversight and Contract Negotiation:

The Capitol Biologics' Clinical team support sponsors in finalizing the CRO selection based on in-depth comparative analysis of responses, risk mitigation strategies, and willingness to engage as a collaborative partner.

They contribute to the definition of contract terms, performance metrics, contingency planning, and escalation procedures to ensure expectations are clear and roles are well-defined.

After selection, our team will establish governance structures for ongoing oversight, regular performance reviews, and continuous communication between all parties.

Ongoing Vendor Management:

The Capitol Biologics' Clinical team may remain involved to ensure the CRO delivers on milestones, data quality, and compliance standards, and may participate in joint governance committees to promptly manage emerging risks or required changes in trial execution.

By integrating CRO vetting and bidding into their clinical trial support, the Capitol Biologics' Clinical team helps sponsors de-risk vendor selection, ensures the best-fit CRO is chosen, and maintains robust oversight for high-quality, compliant execution of the clinical trial.

Clinical Compatibility Studies

ICH Q8(R2) 2.6 “Compatibility”

“The compatibility of the drug product with reconstitution diluents (e.g., precipitation, stability) should be addressed…

Also applies to components employed for extended holding or administration of clinical drug product

Capital Biologics can design studies corresponding to established drug product handling and administration to demonstrate in-use stability and product integrity.

Clinical component procurement

Full in-house analytical capabilities to measure impact on product concentration, potential aggregation, potential degradation, potential change in potency

Protocol and Report as deliverables