Idis Managed Access (MA) is the global leader in the specialist management of ethical regulatory compliant and efficient solutions to help pharmaceutical and biotech companies provide early access to promising, innovative preapproval medicines to address unmet patient need worldwide. This means patients get the lifeline they need, and pharmaceutical companies gain the reassurance they require.
Also known as expanded access, named patient, temporary authorization for use, compassionate use, and early access, these terms encompass a variety of different country specific regulatory approaches which are all designed to provide access to medicines outside the commercial and clinical environment. This could be at a number of different stages during the product lifecycle:
- Globally Unlicensed: Drugs still in clinical development, patients who neither qualify for an ongoing clinical trial, nor can get access to a trial site to participate
- Post Trial: Drugs that have completed clinical development and need an efficient way to maintain treatment access for trial participants and beyond until commercial availability
- Phased Launch: Drugs have received marketing authorization in one country, patients from other countries needing access prior to launch in their market
- No Approval: Drugs will never be commercialized in certain countries where patients may still need access
The benefits of implementing a managed access program are significant, not just for patients and healthcare professionals who have run out of treatment options, but for the pharmaceutical and biotechnology companies that hold the products that could help:
Broadens experience with the new therapy beyond the limited parameters of a clinical trial to ensure that early adopter, non-investigator physicians are educated properly in the appropriate use of a drug, driving optimal patient outcomes.
Continuation of care
Allows continuity of patient access from clinical trials to commercial availability in a more efficient, and cost-effective way than with a standard open-label trial extension.
Enables centralized control over who will gain early access to your drug throughout the development lifecycle to reduce the potential risks associated with adverse event occurrences and product counterfeits.
Commercial launch readiness
Identifies global usage patterns, enables the testing of key educational information and provides the ability to understand and resolve any supply chain challenges.
Provides a platform to harvest a wealth of additional information and data.