Our safety and pharmacovigilance services support clinical trial and post-marketing safety surveillance across the globe.
Our pharmacovigilance service is competent to monitor the safety and efficacy of investigational medicinal products and post-marketed products. We ensure reporting obligations are in line with worldwide regulatory requirements and thus contribute to the ongoing risk-benefit assessment.
Our service offering are across all phases of clinical development and post-marketing studies. Our professional expertise ensures safety and risk management throughout clinical development and post-approval. Our expert advisory services help sponsors identify and manage post-marketing setbacks that threaten both product revenues and reputation. By offering this service, we are able to support pharmaceutical companies within specific functions. Our pharmacovigilance service is particularly useful for companies without a dedicated pharmacovigilance department looking for specific and cost-effective solutions for pharmacovigilance tasks.
We offer our services both during clinical development and post-marketing as a complete solution or as stand-alone services.
- Setup and maintenance of global safety databases
- Receiving, Triage and registration, processing and archiving adverse events and reaction information
- Medical assessment of individual cases
- Ensure compliance with local and international requirements
- Safety reporting to Health Authorities and other parties
- MedDRA coding and coding convention strategies
- Medical support for SAE reconciliation
- Preparation of written pharmacovigilance procedures (SOPs)
- Preparation of SAE case narratives
- Interim safety reports (on demand)
- Annual safety reports
- Periodic Safety Update Reports (PSUR)
Clinical Data Management
CAC India Private Limited offers end to end comprehensive clinical data management services from Phase I through to post-marketing trials. We have expertise and experience in all phases of the study, conduct, and close-out activities.
Quality is our motto and we ensure the highest quality and integrity of data while accentuating a strong commitment to meeting all timelines and deliverables. Our solutions-oriented approach to all endeavors and challenges will ensure continuous operational excellence and client satisfaction.
Data Management services:
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- Access to different EDC solutions
- Data Management Plan (DMP) development
- Data Management Project Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
- Query Management
- Medical Coding
- Safety Data Management & Reconciliation
- Data Export/Transfer
- CDASH Compliant deliverables
- Real-time data viewing and reporting
Our Biostatistics capabilities include a broad range of therapeutic experience in phases of trials. Well qualified and highly experienced statisticians who are familiar with the use of SAS and well versed with CDISC standards will ensure that the data used in the outputs produced complies with regulatory standards.
Our biostatistics and statistical programming services:
- Protocols Input
- Sample size calculation
- Statistical analysis plans (SAP)
- Planning and implementing randomization
- Preparing and analyzing integrated Summary of Safety (ISS)/ Integrated Summary of Efficacy (ISE) databases
- PK/PD Analysis
- SAS programming for interim and final analysis
- Statistical Analysis Report (SAR) and listings
- Providing support for regulatory, data safety monitoring board (DSMB) and advisory meetings
A medical Writing capability includes delivering accurate, timely, flexible and cost-effective clinical and regulatory documents of the highest quality and scientific standards.
We have a comprehensive understanding of various Regulatory guidelines such as ICH-GCP, FDA, EMA guidelines and expertise across therapeutic areas.
Our Medical Writing services:
- ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
- Study protocols, amendments, and administrative changes
- Informed Consent Form
- Investigator brochures
- Patient narratives
- Aggregate reports
- Product labeling
- Publications, posters, and abstracts
- Promotional and educational material
CAC India Private Limited offers high-quality results. We have the expertise, dedication as well as capabilities to deliver cost-effective medical coding BPO processes that adhere to best practices and recognized coding standards.
We have a strong and in-depth knowledge of MedDRA and WHO Drug dictionaries and can provide coding of adverse events, medical history, indications, labs, suspect and concomitant products as per industry standards.
Our medical coding help with key points such as:
• Error-Free Coding and Validation
• Stringent Data Security
• End to end process