Trial Design

From initial concept to study protocol and participant informed consent forms (PICFs) development and initial local and regulatory authority submissions. Including creation of core trial documents, processes and supplies according to the unique needs of the clinical trial, including Study manuals, study plans, study documents, Investigator Site Files (ISFs), laboratory/imaging supplies, and other ancillary equipment.

Start-up

We cover study familiarization across all study teams, including:

• Project and operational plans, study plans, kick-off meetings or activation visits, investigator meetings and training for sites, CRAs and other key teams – there is no reason the site and core study team should not be prepared.

• Electronic trial master file (eTMF) development.

Biotstats and Data Management

Data Management, Biostatistics and Statistical Analysis, Electronic Data Capture (EDC) validation, and our Trial Management System (TMS) is comprehensive and includes the following:

•  Database design, testing and production through to database lock and and everything in between.

• Statistical programming and analysis including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) as well as pharmacokinetics/pharmacodynamics.

Study Team Set-Up & Management

Covering vendor identification, selection and ongoing vendor management - finding the right vendor, at the right price, ensures seamless management, on budget and on time.

Safety and Pharmacovigilance

We provide continuous safety and clinical monitoring throughout using qualified and experienced medical monitors, the establishment and scheduling of Data Safety Management Committees (DSMC) and reporting on patient safety and pharmacovigilance.

Site and Study Management

Covering clinical operational oversight from start-up to recruitment and treatment to the follow-up and close-out, through regular study monitoring visits performed by dedicated Clinical Research Associates (CRAs).

Central Pharmacy Management

Covering all study drug handling needs and logistics for your clinical trial, ensuring regulatory compliance and documentation throughout.

Central Laboratory and Imaging Management 

We coordinate activities to ensure timely collection, analysis and reporting that fulfill your protocol requirements.

Clinical Study Report

Bringing all study findings and results together in the final report in line with regulatory expectations and requirements.