CRO & CDMO Oversight
Scendea provides expert Non-Clinical and Clinical CRO & CDMO oversight to maintain quality, safety, and compliance throughout your pre-clinical and clinical trial period.
CRO & CDMO OVERSIGHTWhat is Non-Clinical & Clinical CRO Oversight?
Scendea’s non-clinical and clinical CRO Oversight services help sponsors actively manage and monitor contracted services to non-clinical and clinical Contract Research Organisations (CROs). While many Sponsors delegate operational responsibilities to a CRO, global regulatory agencies, including the FDA, EMA, and MHRA, make it clear that the sponsor retains ultimate responsibility for the quality, integrity, and compliance of their non-clinical and clinical trials.
Scendea’s CRO Oversight services ensure that studies meet regulatory expectations, protect data integrity and participant safety, and stays aligned with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) requirements, without overextending internal resources. Scendea acts as the Sponsor’s on-the-ground team, operating in the same time zone as the trial to provide seamless oversight and continuous support to the CRO, even while the sponsor’s core team is offline.
Why is Non-Clinical & Clinical CRO Oversight Required?
Effective CRO oversight is not just best practice; it is a regulatory requirement. Sponsors must be able to demonstrate active management of their CROs, especially when facing regulatory inspections or preparing submissions.
CRO Oversight is essential to:
Fulfil FDA/MHRA/EMA/TGA and GLP/GCP requirements
De-risk development by giving clients confidence in CRO selection for non-clinical safety and toxicology studies, and assurance in the integrity of non-clinical data
Ensure trial quality, participant safety, and data integrity for clinical trials
Avoid protocol deviations, audit findings, and delays
Identify and mitigate operational risks early
Maximise quality, efficiency, and safety, while minimising costs and timelines
Maintain an appropriate environment for regulatory readiness
Non-Clinical & Clinical CRO Oversight Services
Scendea’s approach is built around three core components:
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We start by conducting a comprehensive risk assessment to define roles and responsibilities clearly between your team, the CRO, and any vendors. This allows us to identify potential risks to data quality, animal welfare, participant safety, and compliance early on. Based on these findings, we develop tailored mitigation strategies and establish your CRO Oversight Standard Operating Procedures (SOPs).
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Throughout the non-clinical and clinical trial lifecycle, Scendea provides continuous oversight of critical study activities. We regularly review key deliverables, milestones, and budgets while monitoring documented processes to maintain a focus on animal welfare, participant safety, data integrity, and regulatory compliance. Our team ensures that all client/sponsor oversight actions are thoroughly documented, enabling you to demonstrate active management of outsourced tasks and maintain inspection readiness, all while helping to keep your trial on track and within budget.
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For trials involving unblinded functions, we offer specialist oversight to safeguard trial integrity. Our services include reviewing unblinded monitoring plans and visit reports, managing Investigational Product (IP) activities such as shipment approvals, stock monitoring, reviewing relabelling procedures, and overseeing study consumables management.
What is CDMO Oversight?
Scendea’s CDMO Oversight services support sponsors in the end-to-end governance and monitoring of outsourced manufacturing partners, ensuring consistent quality, regulatory compliance, and operational performance, and supply reliability. While sponsors often delegate day-to-day manufacturing activities to a CDMO, global regulatory authorities are clear that the sponsor retains ultimate responsibility for product quality, patient safety, and compliance with applicable GMP requirements.
Scendea provides practical, risk-based oversight aligned with GMP and relevant ICH quality guidelines, helping sponsors maintain control of manufacturing activities. Acting as an extension of the sponsor’s team, Scendea delivers proactive oversight to support consistent supply, early issue identification, and ongoing compliance throughout the product lifecycle.
Why is CDMO Oversight Required?
Effective CDMO oversight is not just best practice; it is a regulatory and operational necessity. While manufacturing activities may be outsourced, sponsors remain accountable for product quality, patient safety, and compliance with applicable GMP requirements. Robust oversight is therefore essential to demonstrate control of CDMO activities, particularly during regulatory inspections and throughout product development and commercialisation.
CDMO Oversight Services
Scendea can undertake individual tasks to monitor any of the specific CDMO activities outlined below, or provide personnel to integrate directly with your team, acting as a key resource to support oversight throughout the manufacturing and development process. Our services include:
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We work with your team to define roles and responsibilities clearly, establish effective communication and escalation pathways, and manage contracts and agreements. This ensures alignment on priorities, timelines, and expectations while maintaining operational and regulatory oversight.
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We can monitor compliance with GMP regulations, review critical documentation such as batch records, deviations, CAPAs, and validation activities, and conduct audits as needed.
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Throughout process development, tech transfer, and scale-up, we can review manufacturing strategies and analytical methods to ensure consistency and comparability between development and commercial processes, helping maintain product quality at every stage.
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We can ensure CDMO activities align with regulatory filings, support inspections and agency interactions, and manage post-approval changes. Our approach ensures ongoing inspection readiness and compliance with regulatory expectations.
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We can define key performance indicators, conduct risk assessments, and proactively identify potential technical, quality, or operational risks. Our team supports issue resolution and continuous improvement to optimise CDMO performance.
Why Partner with Scendea?
Scendea delivers expert, flexible, and inspection-ready oversight services. Our team brings hands-on experience from non-clinical and clinical CROs, small biotech companies, and manufacturing facilities, with a strong track record in non-clinical and early-phase clinical development. We also have deep operational and regulatory knowledge across key regions, including Asia-Pacific, the United States, and Europe. We understand how sites operate, how CROs and CDMOs deliver, and how to keep contracted activities running smoothly.
We provide strategic value through a scalable resourcing model, offering partial FTE support without the overhead of a full-time hire. This approach helps maximise quality, efficiency, and safety while reducing costs and timelines.
With Scendea, you gain access to the right people, in the right time zones, ready to make informed decisions and resolve issues in real time.
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