More Services

Services

More Services

On top of its traditional services, Bioforum assists its clients with additional support that helps address our clients pinpoints and needs. As a functional service provider, Bioforum provides alternative approaches throughout the whole clinical trial process.
Functional Service Provider

In addition to our comprehensive data management capabilities, Bioforum offers a team of highly skilled medical writers, clinical data managers, clinical operations leads, clinical trial managers, medical monitors, programmers and statisticians to meet your study needs.

An experienced Functional Service Provider (FSP), Bioforum partners with clients—from emerging startups and small biotechs to nonprofits and academic medical centers to mid-size and larger biopharma companies—to help them scale their teams when and as needed, providing customized support for all types of projects and programs, whether small and specific or large and complex.

The functional outsourcing solution provides sponsors with access to dedicated resources to work across multiple programs while managing costs. It enables companies to ensure a pool of highly qualified personnel available to work on their changing clinical trial project needs. Sponsors gain streamlined communications and a niche expertise based on their specific needs.

Connect with us to learn more about our FSP offerings

Pharmacovigilance

Pharmacovigilance – also known as drug safety – describes the collection, analysis, monitoring and prevention of adverse effects in drugs and therapies, and is an essential function within a life science company.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has significant guidelines for companies conducting clinical trials. Organizations are obligated to set up the right systems and processes to identify, record, report and analyze safety signals that could arise during a trial.
Bioforum provides all the pharmacovigilance services required for your clinical trial.

Services Include:

  • Setup Activities
    • EudraVigilance Registration and Responsible Person (in case there are sites in the EU)
    • Test & submit electronic SUSAR to EMA (in case there are sites in the EU)
    • Safety Management Plan
    • Database setup
    • Legacy case entry
  • Adverse Drug Reaction Case Activities
    • Case entry and QC
    • Case assessment, narrative writing and causality/expectedness assessment
    • Generate CIOMS/MedWatch
    • MedDRA Coding
    • Prepare electronic SUSAR
    • Distribute paper SUSAR to sites (in case customer wishes to)
  • Line listings
  • Authoring of the DSUR (Development Safety Update Report)
  • Strategic pharmacovigilance regulatory
Problem Solving

“You cannot solve the problem until you ask the right question” – Anonymous.

When facing a problem, asking the right questions is crucial in identifying the best course of action. The ability to identify the right question comes from years of experience and expertise in the specific field. Effective problem-solving saves time, cost and frustration for the study team. Therefore, in order to successfully deliver your trial, you will need an experienced professional who knows what they are doing through every step of the way. Someone who knows how to minimize and manage risk, while solving your problems quickly and efficiently. At the end of the day, it all comes down to your data and you need someone who understands the value of your data. You need confidence in your data and with Bioforum, you can always trust that you’ll be in the best hands.

Medical Monitoring

Bioforum’s Medical Monitors have vast experience in drug development, medical device and drug-device studies.

Our medical team is trial and data-savvy, enabling us to provide a seamless multidisciplinary collaboration with Clinical Data Management, Biostatistics, Medical Writing, Pharmacovigilance and Clinical Operations. With experience in various therapeutic areas (TAs) and in all study phases, our medical team is proud of having a holistic approach to the medical services thanks to the vast background in publications, big pharma, biotechnology startups, medical devices and academic research.

Whether you need a medical consultant in-house, intermittent medical resources, or a range of medical monitoring services, Bioforum Medical Monitors are highly-dedicated team players who provide good and clear communication. Their commitment is your clinical trial and they are ready to provide the highest quality deliverables on time.

  • Input on study protocol development, IB, SAP, ICF, CRFs, site selection and training
  • Site interactions for continued medical monitoring support including eligibility, stopping rules and deviations
  • Medical planning and medical data reviews
  • Risk identification and mitigation plan and review
  • Oversight on medical coding, SAE reports, narratives and AoSEs
  • Medical input on regulatory submissions
  • Clinical study report (CSR) review