Pharamaco vigilance
Technospark offers complete Pharmacovigilance services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.
Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies. The regulations on safety monitoring have become stringent and are periodically revised. This has led to increased safety data collection, analysis and regulatory surveillance, which in turn has increased costs. You, therefore, need a strategic partner with process expertise–one who can minimize your cost pressures while unlocking value and maintaining compliance.
Technospark Pharmacovigilance is uniquely focused on providing comprehensive and customized Pharmacovigilance (PV) services and offering specialized services to augment or support any drug safety department, tailored to fit your needs.
Experienced and qualified project managers are your primary contact point; they are responsible for project initiation, continued management of your PV needs and will anticipate potential future needs.
The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfill the stringent obligations. Technospark’ Pharmacovigilance team is comprised of Medical & healthcare professionals with vast experience in both direct patient care and industry-specific Pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services.
CLINICAL TRIAL SAFETY:
- Serious adverse event (SAE) management including collection, documentation, active query process and follow-up
- SAE processing within required timeframes in client's database (e.g. Clintrace™ and ARISg™, Argus Safety Database) and other non-commercial systems.
- Qualified medical review of all SAEs for data completeness and medical sense
- Appropriate Medical Dictionary for Regulatory Activities (MedDRA) coding
- Regulatory reporting to authorities, investigators and ethics committees
- Preparation and submission of annual safety reports (ASRs)
- Data reconciliation of Pharmacovigilance and clinical trials databases
- Writing of patient safety narratives for study reports
- Project-specific standard operating procedures (SOPs)
- Compliance monitoring
- SAE training for investigators and monitors
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