London, UK: +44 (0)333 332 1882 | Cambridge, Massachusetts: 617-674-2650 | San Mateo, California: 650-378-1270

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Global Drug Safety Solutions

We help pharmaceutical and biotechnology companies ensure compliance with evolving global and European regulations in various areas of drug safety. Our solutions in Pharmacovigilance Systems, QPPV services and Drug Safety spread from ad hoc consultancy on scientific or operational aspects to packaged solutions, crafted to your specific circumstance. 

Safety management in clinical trials



We will help you ensure robust safety surveillance in your clinical trials, which includes:

  • Definition of safety strategy in clinical studies, including patient selection criteria, parameters to be monitored, guidance for investigators
  • Establishing a robust safety reporting process from sites to the sponsor, including initial and ongoing training of site personnel 
  • Single case assessment, processing in the safety database, medical review and generation of requests for information
  • Identification of cases for regulatory reporting, unanticipated problems, unblinding, analysis of similar events for US IND
  • Expedited reporting, generation and distribution of MedWatch and CIOMS reports
  • Communication of urgent safety mesures
  • Periodic reporting (DSUR, biannual safety reports)
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Pharmacovigilance System and EU QPPV Services



We will help you ensure compliance with European legislation that puts some requirements to companies wishing to market pharmaceutical products in the EU:

  • Establishing pharmacovigilance system and procedures compliant with the EU requirements
  • Designation of Qualified Person for Pharmacovigilance
  • Ongoing oversight of the system, PSMF and products to ensure compliance

 

Risk Management and Periodic Reporting



The main activities of Drug Safety Science:

  • Ongoing Benefit/Risk assessment
  • Periodic reporting - DSUR and/or PSUR, periodic SUSAR reports
  • Signal detection and evaluation, issue workup
  • Risk Management Plans, developmental RMP from First in Human studies
  • Safety sections of Common Technical Document
  • Updates of Safety Reference Information (IB, SmPC, USPI, CDS)
  • Literature search and review
  • Translational safety - potential implications of pre-clinical safety findings
  • Compound preparation for divestment
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Pharmacovigilance Database: Data Entry, Medical Review and Expedited Reporting



Leading safety database

Regulatory expectations regarding compliance with expedited safety reporting requirements are very high. This is why we use one of the most reliable global safety databases on the market. 

 

High quality standards

We ensure that all relevant data reported is accurately reflected in the database, and reviewed by physicians to maximise the value of safety reports. When necessary, we raise queries to resolve inconsistencies or collect important details. 

 

Tight timelines

We work to short timelines to meet regulatory expectations and to minimize the number of follow-up safety reports expedited to clinical sites, regulators and ethics committees.

Safety Due Diligence



When you are facing an in-licencing, co-development, co-marketing or another decision that requires assessment of an external compound, we will be happy to assess review presented data under strict confidentiality applying a factual, independent and impartial approach associated risks, their likelihood, impact and suggest mitigation