Allergan, Inc. is a global specialty pharmaceutical company that develops and commercializes innovative products for the eye care, neuromodulator, skin care, and other specialty markets. In addition to its discovery-to-development research programs, Allergan has global marketing and sales capabilities in over 100 countries that deliver value to its customers, satisfy unmet medical needs, and improve people's lives.
Allergan faced the issue of a failed clinical trial due to doctors and nurses who were inadequately trained on the proper injection procedures for one of their premier products, BOTOX®, a therapeutic muscle-relaxing agent for the treatment of certain neuromuscular disorders. Furthermore, clinical trials were being affected by data invalidated by patient bias due to patients inadvertently learning from medical staff whether they were being administered the actual product or a placebo.
As a result, Allergan's time to market was being delayed which generated inordinate time and financial costs before a product was ever launched. The pharmaceutical industry is fiercely competitive, a delay in the launch of any product has significant implications.
After managing a complicated process in the past, Allergen implemented the MERGE Portal platform, a centrally located, web-based Clinical Trial system that would ensure doctors and nurses were being trained and tested effectively. Upon successful testing, the doctors and nurses received an electronic accreditation for completion of each learning module.
Of specific importance was the assurance that clinicians “checked out” successfully on Allergan's “Pre-Empt” injection procedures for this clinical trial. Additionally, the system provided real-time, auditable visibility by automatically tracking and inspecting the details of all activities of the clinical trials while keeping key stakeholders informed.
Real-time results allowed Allergan to track the knowledge of each medial professional. With knowledge in hand, Allergan was then able to make course corrections where required in order to keep clinical trial results validated and available for all stakeholders.
Through the use of the MERGE platform, Allergan was able to gain greater insight into its training processes. These training processes helped Allergan complete its stage three clinical trials faster. As a result, Allergan is now better able to provide the FDA with tracked, historical, accurate data, which verifies that medical staff were trained and that any bias was removed in disseminating information to patients, thereby improving the success of future trials.