Customized Solutions Adapted To Your Therapeutic Areas
All therapeutic areas face specific challenges, from patient populations to endpoints, assessment instruments and other strict study design requirements. If those needs aren’t properly understood, your goals will not be met. Therefore, it is crucial to partner with an experienced contract research organization that has a solid understanding of the clinical development process and breadth of therapeutic areas expertise.
- Our scientific background, experienced teams and in-house therapeutic expertise will provide you with effective study design, start-up and management. We will tailor seamless solutions, specific to your clinical trial therapeutic area.
- A significant portion of IDDI employees have scientific background in specific therapeutic areas.
- IDDI’s broad range of expertise is reflected in its expert publications in various medical and statistical journals and through its presence at major meetings and congresses (list provided on request).
- IDDI’s in-depth experience had been gained from involvement in over 1046 clinical trials across a wide range of therapeutic areas – handling drug, diagnostic and medical device issues, as well as assisting clients in obtaining 20 FDA/EMA approvals.
Experience in the Main Therapeutic Areas:
|Experience over the last 5 years||Global Experience|
The company has been involved in 15 marketing approvals
|249 trials||720 trials|
IDDI’s contributed methodology and technology supported Macugen® marketing approval.
|37 trials||124 trials|
|9 trials||51 trials|
|24 trials||45 trials|
|10 trials||33 trials|
|Currently involved in 12 clinical trials, primarily related to the second generation of monoclonal antibodies.|
|IDDI has worked on 85 orphan drug studies|
Other Significant Therapeutic Areas:
• Infectious diseases (hepatitis B, hepatitis C), central nervous system, autoimmune diseases, nutrition, orphan diseases.
• Medical devices: Our processes conform to medical device studies, both for pilot and pivotal studies.
• We help our clients achieve the European Conformity CE marking and FDA approvals for medical devices.
• IDDI has successfully helped a cardio-vascular device approval in the US, and validation of a cancer diagnostics product also submitted to the FDA.
Breakdown of Trials by Therapeutic Area (number of trials over the last five years):