|Type||Public / Private|
Cmed is an innovative, full-service, technology-led CRO, established in 2000 by a team of experts passionate about helping customers deliver highly successful clinical trials. We bring together an experienced team and our own innovative technology to inspire and drive real progress throughout the clinical trial process – for every step, every solution, every study. Our vision is to conduct clinical trials better than anyone else to help patients and ultimately save lives.
We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials in various therapeutic areas, with considerable therapeutic expertise in both oncology and rare diseases.
- Feasibility & Study Start-up
- Clinical Monitoring
- Project Management
- Data Management
- Project Management
- Medical and Safety Monitoring
- Drug Safety & Pharmacovigilance
- Medical Writing
- Regulatory Affairs
- Combination Products
- Pharmaceutical Development
- Full Service
- Functional Service Provision
Drug Safety and 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 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.
Pharmacovigilance activities 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.
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:
- 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 24⁄7.
- 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.
- 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.
Top 5 Recent Tweets
|May 26, 2017||Cmed||Our Regulatory Affairs, Consulting & Product Development arm offers support throughout the product lifecycle.https://twitter.com/CmedResearch/status/868074492085534721|
|May 25, 2017||Cmed||Check out our latest video of the encapsia® eSource App – we hope you like it! https://twitter.com/CmedResearch/status/867711736396345346|
|May 24, 2017||Cmed||Are you attending @ASCO 2017 on the 3-5 June? Visit us at booth 23128 to hear about our oncology experience & encapsia™ clinical data suite. https://twitter.com/CmedResearch/status/867349723543478273|
|May 20, 2017||Cmed||Today is International Clinical Trials Day - celebrating the impact of research in healthcare & the importance of the work that we do daily. https://twitter.com/CmedResearch/status/865900084915044352|
|May 19, 2017||Cmed||Great article by @InformationAge about 'Winning with analytics in the pharmaceutical industry'.https://twitter.com/CmedResearch/status/865537748328894465|