Drug Safety & Pharmacovigilance

Overview

Cmed Medical Services offers comprehensive and dynamic support to Cmed’s Clinical Services CRO, including:

  • Medical and scientific input to clinical study protocols or synopses.
  • Medical and safety monitoring of clinical studies.
  • Medical writing support.
  • Support to Cmed’s Consultancy Services.

Experience is the difference

Our seasoned medical staff have extensive experience in the pharmaceutical and CRO industry, including:

  • All phases of drug development (TM, I-IV) – strongest in early phase and first-in-human to Phase II POC clinical studies.
  • Multiple therapy areas, especially oncology and rare diseases, immune-inflammation, respiratory, gastrointestinal and CNS disorders.
  • Studies involving a wide variety of compounds including: small molecular entities (NCEs), biopharmaceuticals (monoclonal antibodies, antibody fragments, antibody drug conjugates and immune check point inhibitors), vaccines, cell therapy (including CAR-T cells),gene therapy products and medical devices.
  • This group is supported by a network of KOLs, established relationship with investigative sites and scientific advisors who can provide guidance on a project-by-project basis.

Medical and Safety Monitoring

Our medical and scientific team members have experience in the biopharma and CRO industry – as well as direct experience as practicing physicians. At Cmed, our medical monitor coverage is designed to assist sites with study-related questions including safety reporting issues; discussions regarding inclusion/exclusion concerns and deviations; safety trending analysis; and patient management questions.

The Cmed medical team provides insight into clinical practice at all phases of study conduct:

Start-up activities
  • Provide protocol input; review protocol and electronic case report forms (eCRFs).
  • Aid in study design, in collaboration with external consultants and sponsor as required.
  • Conduct Investigator/Key Opinion Leader (KOL) recruitment, communication and management.
  • Review safety monitoring plan and statistical analysis plan to provide insight.
  • Address site initiation and enrollment issues.
Ongoing trial activities
  • Be available 247.
  • Conduct frequent calls to investigators throughout trial to ensure site remains at a “steady state”.
  • Actively work with clinical research associates (CRAs) and project managers on day-to-day patient care and medically relevant study conduct issues to ensure the trial runs as smoothly as possible.
  • Assist sites with inclusion/exclusion criteria questions.
  • Assess need for protocol amendments.
  • Collaborate with sponsor medical and pharmacovigilance teams.
  • Review lab reports, safety reports and protocol deviations.
Close-out activities
  • Development of safety reporting.
  • Overview and review of Clinical Study Report (CSR).

Cmed’s eClinical technologies enable the team to quickly monitor and react to any medical issues from the clinical study, allowing Cmed to keep you informed at every step.

Drug Safety & Pharmacovigilance

A reliable team for reliable services

Pharmacovigilance is incredibly important – and takes incredible skill to do well. Let Cmed help you ensure your trial’s medical safety, conducting safety management from clinical development to post-marketing. Our expert team provides a comprehensive global approach to safety reporting, either as part of a full service solution or as part of your team. Years of experience across multiple therapeutic areas; global reach; and in-depth regional knowledge ensure success in your drug safety efforts. With Cmed, you can focus on other aspects of your product development, knowing that we’re monitoring your patient safety and risk/benefit profile.

Our Pharmacovigilance services include:

  • Serious Adverse Events occurring during a clinical trial are notified to Cmed, using trial-specific SAE forms. We fill in the blanks and follow up on missing information.
  • All SAEs are entered into a trial-specific area in our ARISg™ database. Regular listings can be provided to the client as requested.
  • A registered medical practitioner is available to review safety information and respond to any questions raised by members of the team.
  • A medically qualified person reviews all SAEs for relationship to study medication and expectedness according to IB or product information.
  • We write safety narratives and follow them to resolution.
  • SUSARs for medications or devices reported to the regulatory authority(s) as required (TGA, FDA, EMA) – with follow-up.
  • Experience with DSURs and PSURs.
  • Submissions to the authorities.
  • If there is a DSMB constituted for a clinical trial, we notify all SAEs and conduct follow up.
  • A medically qualified person reviews all adverse events in the clinical database at regular intervals and reports any safety issues/trends to the sponsor and the DSMB chair.

Praise from our customers

Our sincere thanks for an amazing management of submissions – no hiccups, all on time, very smooth. Thank you!

Medical Writing

Effectively leading the preparation and delivery of medical documents is an art. Our medical writers work closely with our customers, for example by leading key meetings and ensuring all the required quality controls are in place. Every document undergoes thorough scientific, statistical and editorial review.

Our medical writers have a wide breadth of knowledge and experience drawn from experiences in the pharmaceutical industry, other CROs and in academia. This experience helps us consistently meet timelines for the development of clinical documentation – with high-quality writing that reduces the need for additional review and re-work, saving you time and money.

Wide range of services

  • Clinical trial documents (Protocols, Study Reports)
  • Development documents

For anything not listed here, please contact us and we will be happy to evaluate.

Praise from our customers

It was so easy to complete this project with you. We had to rely on your expertise and leadership to bring this last effort to conclusion. And you could bring all the pieces together – we could just SEE it!

Want to learn more?

Please feel free to contact us if you would like to learn more about our skills and experience. We are friendly, open and here to help.

Contact us