Early Access

Early access to Investigational

Medical Products

At Adroit Clinicals, we are devoted to developing transformative therapies for people facing rare and life-threatening diseases. We seek to provide these therapies to the broadest group of patients possible by engaging in clinical research with the goal of obtaining regulatory approval of our products.

If a patient is unable to gain access to an unapproved or investigational medical product through a clinical trial, they may be able to gain access to this investigational medical product via an early access program, if this is available. Our goal, whenever possible, is to encourage patients to participate in clinical trials. Overseen by a team of medical experts, clinical trials are designed to determine whether an investigational medicine is safe and effective for patients.

However, we recognize there are specific circumstances when enrollment into a clinical trial is not feasible and Health Care Professionals (HCPs) caring for patients with serious or life-threatening conditions or diseases may seek early access to investigational medical products. Adroit Clinicals will evaluate such requests on a case-by-case basis based on specific pre-defined criteria and the circumstances of the request concerned.

When evaluating requests for early access outside of a clinical trial, Adroit Clinicals will generally consider the following aspects:

• An independent request has been received from a qualified, licensed, treating HCP.
• The patient suffers from a seriously debilitating or life-threatening disease and there are no comparable or satisfactory alternative therapies.
• The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational medicine and the benefit outweighs the known or anticipated risks.
• The patient is ineligible for, or otherwise unable to participate in, a clinical trial. 
• Adroit Clinicals has sufficient supply of the investigational medicine, and logistical capacity to supply it.
• Providing the investigational medicine will not interfere with ongoing or planned trial(s) or with the overall development program.
• The requesting HCP is willing to:
• Obtain informed consent from the patient or guardian.
• Obtain all necessary approvals or licenses.
• Early Access is possible under local requirements in the jurisdiction concerned.
• Access to the investigational medicine will end should the therapy become commercially available for the relevant indication in the patient’s country of residence. Adroit Clinicals reserves the right to discontinue, at any time, access to an investigational medicine.
• Safety and monitoring requirements can be met.

Additional factors specific to a particular request may also be considered.

A qualified, licensed treating HCP may submit a request for early access to our investigational medical products, discuss eligibility, or ask other questions by submitting an online form. Please contact us at [email protected] for information prior to submitting a request for early access to therapy outside of a clinical trial. We will use our best efforts to acknowledge each submitted request within 2 business days after receipt of the written request and the completed application documentation. Adroit Clinicals will promptly evaluate a request after such acknowledgement in compliance with local laws and regulations.