Regulatory Affairs Specialist Launches Clinical Trials Services

ELC Group has launched a new Clinical Trials service for pharmaceutical customers worldwide. The new, end-to-end service offering spans bioavailability/bioequivalence (BA/BE) and phase I studies, phase II to phase IV and post-marketing surveillance (PMS) studies, medical writing, biostatistics and statistical programming services, clinical data management (CDM), good clinical practice (GCP) audits and training. The new portfolio has been developed specifically to help customers expedite the regulatory submission process and speed time-to-market.

For phase I studies, ELC Group is providing its pharmaceutical customers with full regulatory consulting support, protocol design, assistance with ethics committee submissions, plus access to a Clinical Pharmacology unit and bio-analytical testing — delivered from a centre that is approved by all major regulatory agencies. Additional services include clinical study management, method development and validation, data management, pharmacokinetic (PK) analysis, statistical analysis and report writing.

For phase II to phase IV and PMS studies, ELC Group now offers a full range of services, including study feasibility, site and investigator selection, site monitoring, project management, clinical trial supply management and vendor management.

As part of its Clinical Trials portfolio, ELC Group is also providing expert biostatistics and statistical programming services — covering all major therapeutic areas — and delivering insights into trial design as well as developing complex statistical analysis plans. In addition, ELC Group now offers CDM services for early clinical development and late phase clinical development programmes, including managing data for pharmacovigilance and pharmacokinetic/pharmacodynamic (PK/PD) services.

The new service portfolio is rounded off with ELC Group’s GCP auditing, quality assessment and risk analysis services, plus GCP training and workshops for the Institutional Review Board/Independent Ethics Committee (IEC/IRB). All services are complemented by ELC Group’s expert medical writing capability for regulatory submissions, scientific communications and medico-marketing material.

Commenting on the Clinical Trials service launch, Marco Rubinstein, CEO of ELC Group, said: “With our new Clinical Trials portfolio, we are delivering a full-service solution to help ease the regulatory approval process and shorten key timelines for our customers. Our Clinical Trials services are fully customisable and can be offered on a standalone basis or as part of our integrated full-service package, offering ultimate flexibility to our pharmaceutical customers looking to expedite product delivery and create a competitive advantage in the market.”

ELC Group, +42 22 491 00 00, ajain@elc-group.com, www.elc-group.com.