Clinical Affairs

Our end-to-end service offering spans Strategic designing of Pre-clinical & Clinical development programs for drugs and devices including Pre-clinical studies, Bioavailability/Bioequivalence (BA/BE) and Phase I studiesPhase II to Phase IV and PMS studiesMedical writingBiostatistics and Statistical Programming Services, Clinical Data Management, GCP Audits and training.

Our comprehensive Pre-clinical & Clinical study services provide the expertise and capabilities necessary at each stage of development by providing the client with an end-to end service model, thereby accelerating the overall clinical development phase of a drug or a device.

Pre-clinical services provided by ELC are designed to generate adequate and robust pre-clinical data using both in vitro and in vivo models in accordance with national and international guidelines (covering ICH, EU, US FDA, and OECD Guidelines).

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 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 offers Clinical Data Management services for early clinical development and late phase clinical development programs, including managing data for pharmacovigilance and Pharmacokinetic/Pharmacodynamic (PK/PD) services.

The clinical affairs 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.