Preclinical & Clinical Studies
ELC Group works with a first-class network of validated clinical research organisations (CROs) to provide expert experience, skills and knowledge to take pharmaceutical products from concept through to distribution. We offer independent oversight and project management 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.
Early phase and BA/BE studies
- Phase-I studies .i.e. First-in-Human / First-in-Patient, and Healthy Volunteer Studies
- PK/PD studies
- Drug-Drug Interaction Studies
- SAD/MAD studies
- Food Effect Studies
- Special Population (like Hepatic and renal impairment studies)
- Bioequivalence/bioavailability studies
Our comprehensive bioavailability (BA) and bioequivalence (BE) studies service incorporates regulatory consulting, protocol design, ethics committee submissions, a clinical pharmacology unit, and bio analytical testing. We also offer expertise in clinical study management, method development and validation, PK analysis, statistical analysis and report writing. Our centers are approved by all major regulatory agencies.
Phase II to Phase IV and PMS studies
We enable every aspect of the clinical trials study process, including:
- study feasibility
- site and investigator selection
- site monitoring
- oversight of clinical operations
- clinical trial supply management
- vendor management
- independent audit
We can also offer a customized service which can be delivered on a standalone basis or as part of an integrated full-service offering.
Clinical Data Management
- Creation of data base and Set up
- CRF Design
- Creation of Project specific Guidelines
- Database Set-up
- Query Programming and Validation etc.
- CRF Tracking Set-up
- Double Data entry & verification
- Query Management
- Clinical data Coding
- Data Import/Export
- Audit trails and access log maintenance
- Project specific Document Management
- SAE Reconciliation
- Statistical analysis of Bioequivalence studies
- Sample size calculations
- Statistical Analysis
- Confidence Interval
- Sample size calculation for all Phases I-IV
- Statistical analysis plan
- Analysis and Interpretation of all reports
- Preparation and review of datasets
- Quality requirements in statistics
- Strong statistical skills; working knowledge of theories in mixed linear models, non linear model, survival analysis, censored data, method for rate and proportions, repeated measures, generalized estimating equations, equivalence testing, cross over design
- Generate reports describing the sources of data, significant differences and relationships among these sources and the limitations on data reliability or usability.
- Expertise in critical review of documents, guidance documents viz. clinical study reports, abstracts, posters, clinical trial synopsis, clinical trial registries, standard operating procedures, user manuals and forms
The primary objectives of GCP quality audits are to ensure that the rights of trial subjects are respected (as per the Declaration of Helsinki) and that the integrity of the trial data can be assured. Sponsors of clinical trials are expected to implement quality systems and processes with procedures that assure the quality of every aspect of the trial, and these systems and processes are subject to regular audit.
Routine audits of clinical trials can be scheduled during any phase of development and at any time during the conduct of the trial.
Scope of GCP Audits
- Investigator Site
- BE / Clinical Study CRO
- Third party service provider
- Clinical trial central pathology laboratory
- Investigational product depot/supplier
- IWRS/IVRS service provider