• Phone: +44 (0)1476 570819
  • Email: bd@drugsafetysolutions.co.uk
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SUPPORT

We Take Care of All Your Pharmacovigilance Needs!
We, at Drug Safety Solutions, are thoroughly aware of the fact that biopharmaceutical and pharmaceutical companies need to ensure that their Pharmacovigilance (PV) and Medical Information (MI) needs are being managed efficiently and correctly. This is the reason why a significant share of our regulatory services are focused on efficient Pharmacovigilance Case Processing and Reporting Services.
Our Qualified Person Responsible for Pharmacovigilance (QPPV) excel in offering a competitive and accurate Adverse Event Reporting (ADR) system. By affiliating with the professionals at Drug Safety Solutions, our clients get entitled to an extensive range of services for their product life cycle.

Case Processing and Reporting Services You Can Trust!
Having plenty of years of experience under our belt, we, at Drug Safety Solutions, have been excelling in processing Individual Case Safety Reports (ICSRs) and drug safety data for our clients from pharmaceutical and biopharmaceutical companies. We offer cost-effective solutions for effectively managing your company’s’ safety data while also taking preventive measures for your company’s future ICSRs processing needs. Ensuring Product Safety during clinical trials yield accurate safety information which helps in providing better overall protection. Our experts excel in processing diagnostic results and medical histories, ensuring the validity of each reported event.
Our case processing and reporting services include the following:

  • Periodic Safety Update Report PSUR
  • Development Safety Update Report DSUR
  • SUSAR Reporting UK

Clinical Trials Support
When it comes to adequate provision of pharmacovigilance services during the clinical development stage, we, at Drug Safety Solutions, offer bespoke scalable services that are certain to meet your needs. With our complex, global, and multi-centred clinical trials support, our clients are entitled to the following services:

  • Project Management for Drug Safety
  • SAEs Collection and follow-up during clinical trials
  • Electronic management of SAEs
  • Advanced reporting to Competent Authorities
  • Bi-yearly and quarterly reporting to Ethics Committees and Competent Authorities
  • Clinical database reconciliation
  • Reviewing and overseeing Compliance
  • Signal Detection
  • Round the clock coverage

Professional, Timely, and All-Inclusive – This is How We Work!
Our bespoke solutions are strategically designed to cater to your company’s PV needs, including end-to-end case processing, clinical trial support, case processing and reporting etc. Our team of PV professionals have been recruited after extensive training and have several years of experience when it comes to providing preeminent solutions to your specific needs. We strive to help our customers, matters not what product lifecycle stage they are at. We aim to assist organisations while strictly meeting the regulatory requirement by ensuring a carefully validated safety database. From efficiently managing the risk-benefit profile of the drugs to helping companies on how to introduce drugs to market quickly, we excel in providing services you can count on!