Scientific Services Offered
Our clinical trial department offers a variety of services to researchers, sponsors, and healthcare organizations. These services ensure ethical compliance, study design, and accurate data generation. Below is a categorized list of scientific services:
1. Regulatory and Ethical Approvals
- Submission and facilitation of study protocols for IEC review and approval.
- Preparation and submission of regulatory documents to national and international authorities
2. Study Design, Protocol Development and execution of clinical trials
- Designing and conducting clinical trial protocols, including Phase I-IV studies.
- Development of study-specific documents such as:
- Informed Consent Forms (ICFs)
- Investigator Brochures (IBs)
- Case Report Forms (CRFs)
- Standard Operating Procedures (SOPs)
- Biostatistical services for sample size calculation, randomization, and endpoint determination.
3. Site and Investigator Management
- Identification and qualification of trial sites.
- Training of investigators and site staff on Good Clinical Practices (GCP) and protocol-specific requirements.
- Periodic monitoring visits to ensure compliance with the protocol and ethical standards.
4. Participant Recruitment and Retention
- Development of recruitment strategies tailored to the target population.
- Management of informed consent processes and participant education.
- Strategies for retention and follow-up of study participants.
5. Data Management and Analysis
- Design and implementation of electronic data capture (EDC) systems.
- Data entry, validation, and quality control.
- Statistical analysis of study data, including interim and final analysis.
- Preparation of data reports for submission to ethics committees and sponsors.
6. Safety Monitoring and Reporting
- Monitoring and management of adverse events (AEs) and serious adverse events (SAEs).
- Preparation and submission of safety reports to IEC and regulatory authorities.
- Data Safety Monitoring Board (DSMB) support and coordination.
7. Specialized Clinical Trial Services
- Conduct of bioavailability and bioequivalence (BA/BE) studies.
- Support for observational, interventional, and adaptive trial designs.
- Pharmacokinetic (PK) and pharmacodynamic (PD) study services.
- Assistance with post-marketing surveillance (PMS) studies and Phase IV trials.
9. Medical Writing and Reporting
- Preparation of clinical study reports (CSRs) in accordance with ICH-GCP guidelines.
- Development of manuscripts for peer-reviewed journals.
- Abstract and poster preparation for scientific conferences.
