Pharmacovigilance is the most crucial aspect of modern day healthcare, we at Abiogenesis Clinpharm monitors the safety of pharmaceutical products by thorough detection, assessment, understanding and prevention of Adverse Drug Reactions (ADR’s). Every human being responds differently to drugs and treatments because of variations in genomic structure of an individual, we have made pharmacogenomics and genetics being an integral part of Clinical Research.
Pharmacovigilance services include diverse range of activities ensuring safety of medicines. Our team of experts have designed the pharmacovigilance service in such a way to collect, monitor and evaluate adverse events from electronic medical records, biomedical literature, and patient-reported data. Abiogenesis Clinpharm provides pharmacovigilance services that include reporting adverse events, safety signal detection, assessing & evaluating risks, risk management, post marketing surveillance & regulatory reporting.
- Adverse Event Reporting
- Safety Signal Detection
- Risk Assessment and Evaluation
- Risk Management
- Post marketing surveillance
- Regulatory Reporting
- Case Study Updates
- Data unification
- Risk Management
- Real World Evidence
Adverse Event Reporting
We at Abiogenesis Clinpharm collect the adverse event reports (AERs) from healthcare professionals, patients, clinical trials and from outside sources or digital platforms that can be Electronic health records, biomedical data. Thus, our pharmacovigilance service act as a link between the premarketing data and human safety information that is collected in the Phase IV of clinical trials.
Safety Signal Detection
Abiogenesis Clinpharm being a pharmacovigilance service provider analyzes the reported adverse events for early detection of safety signals.
Risk Assessment and Evaluation
We are determined to identify signals to evaluate the risk posed by the drug or treatment where we consider factors such as adverse event seriousness, its frequency, patient demographics, and the drug’s usage patterns
Risk Management
Our team of professionals do the needful risk assessment and evaluation and works on risk minimization strategies that include updates to labeling of product, interaction with healthcare providers, or even restrictions in specific patient populations regarding drug use
Post marketing surveillance
We at Abiogenesis Clinpharm do the continuous detection of any risks that didn’t come up during clinical trials, thus we go for an ongoing process for monitoring the drugs post approval which is done effectively by our pharmacovigilance team
Regulatory Reporting
Our team of experienced professionals collaborate with pharmacovigilance professionals, companies, regulatory authorities for timely reporting of safety concerns which is done by our team through periodic safety update reports, spontaneous reports
Our dedicated staff maintains an efficient Pharmacovigilance database systems to provide pharmacovigilance services to pharmaceutical companies, biotech companies.
Case Study Updates
Abiogenesis Clinpharm capture and manage individual case study reports of any adverse drug event according to the terminology defined in MedDRA and the related cases by thorough investigation.
Tools
Our company uses several tools and automated algorithms like SAS programming to provide pharmacovigilance services such as safety signal detection and analysis.
Data unification
We at Abiogenesis Clinpharm collects the data from clinical trials, electronic health records, medical literature and then unify it according to the MedDRA terminologies and Natural Language Processing tools
Risk Management
Our experts and experienced staff uses Risk Management Module, Benefit-Risk Assessment Tools to investigate and evaluate risk that is helpful in making decisions regarding risk minimization and safety concerns.
Real World Evidence
We at Abiogenesis Clinpharm provide real world evidences by gathering and collecting data from real world sources such as EHR’S, patient registries to generate meaningful insights regarding the use and benefits of medicinal products by doing efficient statistical analysis.
Our team also conduct observational studies, retrospective analysis based on research requirements besides ensuring compliance with FDA or EMA. Thus at Abiogenesis Clinpharm we offer consultations based on RWE findings to provide recommendations for drug development strategies, market access or post marketing surveillance.
