Clinical Trials & Investigations

Elevate your product’s clinical evidence generation with our Clinical Trials & Investigations service—providing senior clinical leadership, robust trial design, independent oversight, and on‑request CRA support for pharmaceuticals and medical devices. We act as your external clinical function: we design studies, define the clinical strategy, and govern quality and regulatory alignment, while your team or appointed CRO manages day‑to‑day operations. This model gives you access to experienced clinical leadership (and, where needed, hands‑on CRA capacity) without the cost of a full internal department.

Key Features

External Clinical Function and Study Governance

We serve as your senior clinical lead for both pharmaceutical trials and MedTech clinical investigations. We define the clinical strategy, approve key design choices, and ensure that studies are scientifically sound and aligned with your regulatory pathway. Operational execution (site management, monitoring visits, data entry, etc.) remains with your internal team or CRO.

Trial Design and Protocol Development

We develop fit‑for‑purpose clinical trial and investigation designs and protocols, tailored to your product type:

• Pharmaceuticals: interventional and observational trials aligned with ICH‑GCP and relevant regulatory expectations.

• Medical devices and IVDs: pre‑market and post‑market investigations under EU MDR/IVDR and FDA pathways, including endpoint selection, comparator justification, and risk–benefit rationale.

We do not act as the operating CRO; instead, we ensure that the design and documentation are robust enough to support submissions and withstand scrutiny.

Start-Up Support and Regulatory Alignment

We support clinical start‑up by preparing or reviewing core documents such as investigator brochures, informed consent forms, case report forms, and submission‑ready packages for Ethics Committees, Competent Authorities, and IRBs. We ensure that your trial design and documentation are consistent with your overall regulatory strategy and intended claims, for both pharma and device programs.

Independent Monitoring Oversight and Quality Assurance

Where a CRO or internal team performs on‑the‑ground monitoring, we provide independent oversight and quality assurance. This includes:

• Review of monitoring plans and site selection criteria

• High‑level review of eTMF structure and key trial documents

• Periodic quality checks to support data integrity, patient safety, and inspection readiness

We do not replace your CRO; we add a senior clinical layer of governance and control.

CRA and On-Site Monitoring Support (On Request)

In addition to clinical leadership and oversight, we can provide hands‑on CRA services for selected studies, including site qualification, initiation, routine monitoring, and close‑out visits. This is offered on a project basis for both pharmaceutical trials and MedTech clinical investigations, either as your sole CRA resource or to supplement your existing CRO team.

Clinical Study Reports and Integration into Submissions

We author and review Clinical Study Reports (CSRs) and associated datasets, ensuring they meet ICH‑E3 (for pharma) or MDR‑aligned expectations (for devices). We then integrate results into your broader regulatory dossiers:

• Medical devices/IVDs: CER/CEP, PMCF Evaluation Reports, and PMS documentation

• Pharmaceuticals: clinical sections of marketing authorization or variation dossiers

Our focus is on turning trial results into clear, submission‑ready evidence.

Pre-Market, Pivotal, and Post-Market Studies

We support the full study lifecycle:

• Pre‑market and pivotal studies to establish safety and performance (devices) or efficacy and safety (pharmaceuticals).

• PMCF investigations, registries, and targeted post‑market studies for devices under MDR.

• Post‑authorization safety and effectiveness studies for pharmaceuticals, where required or strategically valuable.

All studies are explicitly linked to your regulatory pathway, claims, and lifecycle plans.

Audit and Authority Query Support

We prepare your clinical documentation to withstand audits and regulatory authority queries. We support responses to Notified Body, Competent Authority, and FDA questions on trial design, conduct, and results, and we help you implement corrective and preventive actions where needed.

Perfect for pharmaceutical sponsors, medical device manufacturers, IVD companies, and digital health innovators who need senior clinical leadership without expanding headcount, the Clinical Trials & Investigations service gives you a credible, inspection‑ready clinical function on demand.

Partner with us to design and govern clinical trials and investigations that are scientifically sound, regulatorily robust, and strategically aligned with your development and market access goals.

If you need to evaluate or maintain existing clinical evidence, explore our Clinical Excellence service for CER, PMCF and PMS support.