Pharmacovigilance Services

pharmacovigilance services

Pharmacovigilance

Safety is a key component of any clinical trial. The pharmacovigilance services team at Biosphere helps project sponsors to create safety management plans to avoid unfortunate trial outcomes. Maintaining safety standards adds to trial integrity, patient safety and reputation of the project sponsor. Additionally, the safety standards followed by the project sponsor determines the outlook of the regulatory authorities towards the project sponsor.

Clinical trial projects test drug variants to discover a solution to a problem. Every effort is taken care by the trial team to understand the safety concerns in the procedure in a clinical trial project.

Since every project has a different scope, we create a safety management plan by studying all ends of the project that we work on. Biosphere can efficiently deliver the safety reports at a faster pace so that necessary steps can be taken to tackle issues on time.

Service Offered

  • Customised safety monitoring services to suit client needs.
  • Experienced pharmacovigilance team of Biosphere include qualified and experienced project managers, Safety Physicians, Pharmacologists
  • Safety Adverse Events (SAE) management and reporting for clinical trials based on the project scope.

Benefits

  • Project sponsors can ensure the safety of patients/trial volunteers participating in the clinical trials.
  • Following safety standards of the pharmaceutical industry helps in successfully conducting clinical trials.
  • Building and maintenance of a safety database keeps a record of safety issues that were discovered and can be avoided in the future trials.

Speak to a member of our team about our clinical and safety data services

Our expert will work with you to gain insight to your molecule, anticipated outcomes and definite trial requirements and provide a customised design best suited for your molecule.

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