BA/BE and Phase I
FCRL has conducted more than 240Bioequivalence studies for generic pharmaceutical products and two Phase I studies. The Study reports have been submitted by the sponsors to Regulatory Authorities of Brazil, UK, and to most of the EU countries (Finland, France Spain, Denmark, Norway, Ireland, Italy, Poland, Portugal, Germany, Hungary, Ireland, Netherlands etc), South Africa, Malaysia, India and Canada. FCRL has been approved by AFSAAPS (France), thrice by ANVISA (Brazil) and DCGI (India).
Pharmacokinetic studies conducted by FCRL are of different types such as
 Fasting Studies |
| Food Effect Studies |
| Drug-Drug Interaction Studies |
| Multiple Dose and Steady State Studies |
| Dose Linearity Studies |
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Each study is managed by separate dedicated scientific staff. Different groups are responsible for different activities of a BA/BE study:
The Medical Affairs team has dedicated technically sound Protocol Writing Team. This Team prepares the Study protocol in coordination with Investigator, Project Coordinator, Biostatisticians, PK Scientists, and Project Managers.
Some of the key services included in the above area are:
| Clinical development plan |
| Design & development of clinical study protocols |
| Development of CRF, ICF & other documents |
| Bio statistical services for protocol development |
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Subject Recruitment & Screening |
We have a robust database of more than 6000 healthy human volunteers
(male and female) belonging to Delhi NCR region. VDMS – A Biometric based Volunteer Management System ensures that there is no over volunteering and cross participation in the study. This VDMS system is shared between two other CROs in Delhi NCR Region. This has greatly improved the study results for all our studies.
FCRL has access to three independent ethics committees in Delhi NCR region which are structured as per ICH guidelines and serve to facilitate the speedy review and approval of protocols, ICFs and review of clinical logistics at the facility.
Through strong team structures, close communication, and detailed tracking and measurement, the Project Management group delivers consistent high quality services to customers.
All projects conducted by FCRL follow a common project management methodology that provides sponsors with a standardized and disciplined approach to project management. This methodology provides each Project Manager with a set of standards and guidelines to manage projects in the most effective manner.
Project Managers work closely with the sponsor project team from project kick-off and start-up through completion of the final study report or contract closure to meet their objectives. This team approach to project management ensures that the project will be completed according to specific study requirements and timelines. FCRL provides detailed timely tracking of each project to make sure that sponsors consistently know the status of their project. FCRL tracks key metrics and milestones for every project, and by agreeing on these milestones ahead of time with the sponsors, it lays a foundation for effective communication, reporting, continual improvement, and demonstration of success.
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Method Development and Validation |
Our method development groups are committed to develop methods with lowest LOQ and very rapid turn around time.
Methods are validated on LC-MS/MS or HPLC in compliance with norms of US FDA and other applicable regulatory agencies.
We can source Reference Standards, Metabolite, Deuteriated compounds as per method requirement.
1. We provide following bioanalytical support with team of qualified analysts.
2. Analysis of drug and /or metabolic in biological samples
3. Adaptation and revalidation of sponsor’s assay methods
4. Method for drug-drug interaction studies
5. Chiral analysis
6. Analysis of multiple analytes from combination drug products
Analytical group works into three shifts allowing 24/7 operation of our analytical equipment and ensuring that client’s timelines are always met.
Our goal is to provide the accurate analysis in the shortest possible time while maintaining full compliance with regulatory requirements.
The lab offers highly selective and sensitive assays of drugs, metabolites in biological fluids.
QC and QA procedures ensure that our lab produces top quality and credible data with no room for discrepancies.
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Data Management & Statistical Analysis |
Biostatistics team performs sample size determination, statistical protocol development and randomization of volunteers for bioequivalence studies.
SAS programmers convert the pharmacokinetics values to SAS data sets & perform statistical analysis and preparation of statistical report.
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Report Writing & Submission |
We understand the client need for fully integrated study reports while adhering to applicable regulatory guidelines and ICH-GCP norms.
In-house medical writers and project management team are involved in the study at every stage to bring about a comprehensive understanding of study and generate reports that are insightful and accurate.
Final summarized data is available to clients in hard copy as well as electronic file, along with hard copies of reports.
Project management team generates comprehensive study report that includes all aspects of clinical, Bioanalytical, QA & statistics.
At the end of study, FCRL provides a comprehensive report conforming to requirement of ICH, FDA, EMEA etc. needed for regulatory submission. Reports are prepared in requirement of various norms and report formats of regulatory agencies.
For FCRL, Quality Management of its facilities and processes are of premiere importance.
FCRL is audited by:
| ANVISA (three times) |
| AFSSAPS |
| DCGI & DSIR |
| Top Indian Pharmaceutical Companies. |
Our Internal Quality Assurance Team ensures the compliance to SOPs through Prospective as well as Retrospective audits of all the processes. |
