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Global Pharmaceutical Regulatory Affairs Specialist ELC Group Launches Clinical Trials Services


2/20/2013 11:57:50 AM

Cambridge, UK, February 20th 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces the launch of 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 PMS studies, medical writing, Biostatistics and Statistical Programming Services, Clinical Data Management (CDM), 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, 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 Clinical Data Management 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 Good Clinical Practice (GCP) auditing, quality assessment and risk analysis services, plus GCP training and workshops for 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.”

Members of the media interested in scheduling a briefing with ELC Group can do so by contacting Nicky Denovan at nicky[at]evokedset[dot]com.

Press contacts:

Akhil Jain

ELC Group

ajain [at] elc-group [dot] com

Phone: +420 22 491 00 00

Nicky Denovan

EvokedSet PR

nicky[at] evokedset [dot] com

Phone: +44 (0)7747 017654

About ELC Group:

ELC GROUP is a full-service global provider of regulatory affairs consultancy and Contract Research Organisation (CRO). ELC GROUP delivers a complete service solution covering all aspects of Regulatory Affairs for medicinal products, medical devices, cosmetics, food supplements and foods for special medicinal purposes. ELC GROUP also provides specialist REACH regulatory services to the Chemical industry and Corporate Language solutions for Automotive, Chemical and Defense industries.

ELC GROUP’s worldwide network of professionals spans all major Regulatory Affairs services across the key healthcare vertical markets of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary. The team ranges from former FDA investigators to individuals with over 30 years of industry experience and broad capabilities, including in the areas of integrated advanced technologies, Regulatory Affairs consulting and commercialisation services.

ELC GROUP works with equal success in partnership with large multi-nationals, small enterprises and start-ups, biotechs, CROs and device manufacturers.


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