Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

ELC Group now offering comprehensive range of consultancy and support services for clinical trials

Cambridge, UK, February 20 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.”