Expanded Access Programs

Why choose Cmed as your EAP partner CRO?

Up-to-date expertise in the conduct of EAP programs

  • Our team has deep and broad experience in the conduct of Expanded Access Programs (EAPs) ( Compassionate Use Programs, Early Access Programs, or Managed Access Programs, in addition to open label extensions)
  • Our experience spans across a wide range of therapeutic areas supporting patients with unmet needs and rare diseases enabling treatment access to patients with serious or life-threatening conditions.
  • We benefit from our track record of complex clinical programs conducted for both large and small biopharma companies across all trial phases including late phase and Real World studies
  • Understanding the patient journey is an element in all of our trials but is core to EAP studies. Many of our team members have hands-on clinic experience and some were patients themselves. Our patient-centric approach is evaluated during every project and continuously assessed through a project’s lifecycle. This ongoing collection of knowledge is applied in current trials and in strategies for future investigations.
  • Cmed remains an expert in clinical trials for oncology and has extensive experience in ATIMP in multiple therapeutic areas. We are currently expanding several ATIMP projects to protect or continue protecting patients from infection risks.
  • We have strategies in place to accelerate study timelines and get drugs to patients faster including well established decentralized trial set up and monitoring processes.
  • Our regulatory experience is global and set up to identify the best trial types ranging from Investigator Initiated studies to Treatment Protocols. In addition, our continuous exposure to hundreds of Clinical Trials makes us the partner of choice for rapid trial approvals.
  • Safety reporting requirements are understood across the US and all EU countries.

Real World Data collection expertise

  • Cmed has extensive experience in the collection and management of Real World Data (RWD). Data is collected via a combination of options and available immediately.
  • Data flows are widely understood to ensure rapid collection and understanding of data variations.
  • Data quality is at the heart of what we do. More than ever, providing quality data at any given point in time in a clinical trial is essential.
  • Cmed is THE data expert. With experience of over 700 studies, we can provide the expertise, the systems and the customer service you deserve.

Superior technology with encapsia

  • Our clinical trial data system, encapsia, is a single solution that covers eSource, EDC and CDMS. The combination of these options is particularly beneficial for today’s trials which facilitate various entry solutions. Combined with simple data loads to the database, all data are immediately available.
  • Encapsia supports Expanded Access Programs with rapid database build and start-up, flexibility and ease of use, helping provide faster access to treatments for patients.
  • With real-time visualizations, all data are searchable, aggregated and summarized for real-time review. All team members can customize their views of the data to identify trends and outliers. This in turns enables fast turn around and quick decisions.
  • Built-in issue tracking and management is only one of the numerous ways onsite and offsite monitoring is simplified.
  • Encapsia supports rapid expansion and scale of sites and patients, while maintaining high quality data and real-time visibility for decision making

The perfect size, flexible and dynamic

  • We’re a mid-size global CRO with the flexibility, scale and experience to help you deliver your EAP program to patients around the world.
  • We provide the high level of customer service, personal attention, speed, flexibility and 24/7 access to data required for clinical trials today
  • Cmed works as a flexible CRO partner: we take the time to understand the specific needs of your trial so we can give you the best support possible
  • We work with you to determine the most appropriate range of services and the scope of our support to ensure the best fit and the best outcome – from full service solutions to more specific service combinations.

Tell us about your clinical trial
program and how we can help