Clinical Trial Services
From trial supply discipline to clinical delivery.
E-Pharm supports regulated clinical trial supply for sponsors, CROs, hospitals, and study sites. CRO execution is delivered through Abiogenesis Clinpharm under a formal operational partnership. Each study requirement is directed to the appropriate functional team, including Clinical Operations, Regulatory Affairs, Data Management, Pharmacovigilance/Safety, Quality Assurance, Clinical Supplies, and Study Close-out Management, ensuring seamless and compliant trial execution
throughout the study lifecycle.
Partnership
Supply and clinical delivery under one framework.
A formal operational agreement with Abiogenesis Clinpharm governs the delivery of all clinical services with defined accountabilities, shared quality oversight, and a single escalation path. E-Pharm leads supply-related services whilst
Abiogenesis delivers end-to-end clinical study deliverables.
Abiogenesis Clinpharm
Global delivery CRO. Full spectrum. Phase I to IV.
Delivered globally across the full study lifecycle.
- Clinical Operations
- Data Management
- Quality Assurance
- Pharmacovigilance
- Trial Supply Strategy
- Ancillary Supply
- Regulatory Affairs
- Biostatistics
- Medical Affairs
- FSP
- Feasibility & Study Start-Up
- Clinical Trial Technology Services
Why Integration matters
Trials fail at the seams. We remove the seams.
Clinical studies are often managed across multiple vendors, systems, and teams. Whilst each partner may perform effectively within their own scope, the greatest operational risks frequently arise at the points of transition between organisations.
The E-Pharm and Abiogenesis partnership is designed to eliminate these risks through a unified operating framework. With clearly defined responsibilities, integrated quality oversight, and aligned governance, we provide a coordinated approach to clinical trial supply and execution that supports compliance with ICH E6(R3) and enables consistent, reliable study delivery.
Full-spectrum capability
A service map that follows the study itself.
From first feasibility signal to post-marketing surveillance, sequenced to the programme.
Trial Supply Strategy
A proactive approach to clinical trial supply planning that integrates study drug, comparator, and ancillary requirements with enrolment forecasts, regulatory pathways, storage conditions, and global distribution needs. Our strategy helps ensure the right supplies reach the right sites at the right time throughout the study lifecycle.
Feasibility & Study Start-Up
Accelerating study readiness through integrated feasibility and start-up services. We evaluate country, site, and supply requirements, conduct site qualification activities, manage ethics and regulatory submissions, and coordinate CTA and ISF processes to support timely site activation and study initiation.
Clinical Operations
Our clinical operations team drives study execution through a combination of central, remote, and on-site monitoring strategies tailored to study risk and complexity. Supported by a risk-based quality management approach aligned with ICH E6(R3), we provide ongoing site oversight, deviation management, performance tracking, and end-to-end study coordination to maintain quality, compliance, and operational excellence.
Regulatory Affairs
Our regulatory affairs specialists provide strategic and operational support throughout the clinical trial lifecycle. From CTA submissions and substantial amendments to regulatory authority engagement and post-approval maintenance, we help sponsors navigate evolving requirements across the UK, EU, and international markets whilst maintaining compliance and study continuity.
Medical Affairs
Expert medical oversight throughout the clinical trial lifecycle, including protocol review and input, medical monitoring, SAE assessment, safety narrative development, and investigator support. Services are delivered by qualified physicians with relevant therapeutic area expertise.
Data Management
Delivering high-quality clinical data through robust systems, standardised processes, and proactive oversight. Our services include EDC set-up and validation, CRF development, data cleaning, query resolution, ongoing data review, and database lock activities, supported by complete audit trail transparency.
Biostatistics & Programming
Statistical analysis plan authorship, sample size, and interim analyses. CDISC-compliant SDTM and ADaM datasets formatted for regulatory submission.
Quality Assurance
Our Quality Assurance team delivers independent oversight across all stages of clinical development. Through GCP audits, quality risk assessments, CAPA management, deviation review, TMF quality control, vendor management and inspection readiness support, we help sponsors maintain compliance, strengthen quality systems, and prepare confidently for regulatory inspections.
Pharmacovigilance
Safety case processing, SUSAR management, DSUR authoring, and signal detection. Safety reporting across all active study jurisdictions.
Functional Service Provider
Embedded functional teams across any scoped service with defined governance, performance metrics, and explicit exit criteria.
Ancillary Services
Protocol-compliant ancillary supplies and equipment for sites worldwide. Administration kits, sample collection supplies, storage equipment, and patient diaries sourced, documented, and tracked.
Clinical Trial Technology Services
Study technology support across eCRF, CTMS, eTMF and IWRS platforms, aligned to protocol requirements, data integrity, study oversight, essential document control, randomisation, clinical supply visibility, site coordination and quality-led trial delivery.