emas medical and scientific services

Medical and Scientific Services

Medical and Scientific Services Overview

Collectively, our senior medical and scientific staff have been operating in the industry for decades and have wide range of experience in dealing with different issues that tend to arise within this sector. We believe in working with all stakeholders to gain the best results. We will work with you to provide one-off support to bridge a temporary gap, or provide a complete service. The Bionical Emas Medical and Scientific Services team understands the needs of the client in conjunction with their customers, and critically with payers, regulators, prescribers and patients. Our international experience offers a comprehensive support package.

Summary of Services:

  • Medical monitoring support- 24×7 hrs.
  • Medical review of ICSRs, along with review of regulatory documents
  • Medical/Scientific review of promotional and educational material including medical final sign-off
  • Advice on ABPI/ European Code Compliance
  • ABPI complaint support and handling
  • Medical Information Services
  • Maintenance of knowledge base/literature review
  • SOP/WIs preparation
  • ABPI Code advice/training
  • Broad therapy area knowledge/expertise

Medical Monitoring and Medical Review

Our medic team has expertise in the field of Oncology, Rheumatology, Infectious Diseases, Critical Care, General/ Internal medicine and Women’s Health to name a few. Our breadth of knowledge allows us to medically support clinical trials throughout the life-cycle of a product. Our support includes protocol development, medical monitoring activities including writing a medical monitoring plan, signal detection and management, medical review of the ICSRs (Individual case safety report) including SUSARs (suspected unexpected serious adverse reactions), review of various regulatory documents like RMP, PSUR, DSUR, CSR etc.

Patient safety is our priority and we can offer you 24×7 medical monitoring and medical information services.

Medical and Scientific Review and Approval of Promotional Material and Activities

Bionical Emas have a highly experienced team of scientific, medical and compliance reviewers, including final medical signatories, to ensure promotional activities are compliant with regulations, consistent with product labelling and are medically and scientifically accurate.

We can provide support in different ways depending on the client needs and processes, from undertaking the full technical review including regulatory, medical and scientific review in addition to final medical sign-off. Alternatively, we can provide just one aspect of the review, for example if the client intends to keep all final sign-off in house we can provide the detailed technical review only.

We have around 20 years’ experience of working with the UK Code of Practice and also have knowledge and experience of other European codes and reviewing and approving core EU materials for use/adaptation in a number of EU countries.

We like to work closely with clients and their agencies to input early at the material/activity development phase to ensure efficient approval.

Medical Information

The Bionical Emas Medical Information Department supports clients in a number of different ways. Our experienced team have worked in a variety of therapy areas and on products at different stages of the product lifecycle. We can take on the full enquiry service for company product(s) or support in one or more of the following ways:

  • First-line enquiry handling/triage
  • Ad hoc/complex response enquiry handling
  • Standard letter writing service
  • Current awareness service
  • Medical oversight and support
  • Medical writing
  • Out of hours service

Our team are fully trained in AE identification and reporting and have experience of product complaint handling. Bionical Emas’s Pharmacovigilance department can link in to provide a full case processing service if required. Click here to find out further information on Bionical Emas PV Services

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