High-level clinical development and regulatory strategy support
Frequently Asked Questions
IDRE is a global network of R&D professionals with years of experience in the development of pharmaceutical and biotechnology products. Our approach todevelopment is tailor made and makes the best use of the resources available focusing on the product, its profile and future use. This international approach allows companies of all sizes to benefit from the experience and knowledge of specialists worldwide, all working within the same entity.
As the world progresses to a more digitalised era, clinical trials are being driven by adopting new technologies. We bring together a collection of skilled and qualified professionals who have recognised expertise in specialised fields, including data management, virtual trials, and digital devices for trial participants.
KOLs are usually specialists in their clinical arena, and/or academic researchers prominent in their field. They can be a significant asset, able to contribute expertise about the trial and underlying factors and conditions of an illness. They can also encourage other investigators to onboard, and from the sponsors perspective may help lead to faster adoption of prescribing a new drug. IDRE has access to experts and opinion leaders worldwide thanks to many years of experience in the medical pharmaceutical development field.
Selecting a CRO for you to partner with is a critical decision; we use a process of evaluation that includes the below. The management of IDRE is aware that it is very difficult to change a CRO once the project has been initiated. In may occasions, IDRE has often had to support sponsors in such changes, and rescue trials, especially when the sponsor is foreign to the study locations. IDRE selects CROs based on their experience, service portfolio, financial stability, Infrastructure, Processes and Systems, Transparency and Value, Access to Sites and patients, collaborative partnershipand real-time responsiveness.
We have regulatory experts around the world, all of whom implement risk-based interventions, verifying compliance with standard operating procedures and guidelines and protocol requirements, as well as providing audit and inspection support. In addition, they know and understand the nuances of regulatory affairs in their given countries, ensuring communications between sponsors and regulatory authorities are as seamless as possible.