Bionical Emas EAP is the only specialist Early Access Program (EAP) partner to harness the full power of an established and successful Clinical Research Organization. Our global EAP experience in Oncology and rare disease areas is perfectly complemented by a range of in-house services.
The Bionical Emas EAP team provides our clients a superior experience for the benefit of healthcare professionals and patients around the world.
Our mission is to positively impact the lives of patients and their families all around the world. Our goal is to help current and future generations providing timely and appropriate treatment access to patients in desperate need.
myTomorrows is a platform that links patients with an unmet medical need to treatments in development worldwide. We provide patients and physicians with a personalized listing of treatment options, such as Clinical Trials and Expanded Access Programs and can facilitate access to them. We partner with pharmaceutical companies to help find patients for Clinical Trials, run Expanded Access Programs, and collect Real-World data.
The Global Guide to Compassionate Use Programs was developed over four years by industry, government, regulatory, operational, and pharmacovigilance experts with decades of combined experience. This comprehensive resource will save you valuable time by translating and collating information from 61 countries and helps navigate the complex and often confusing individual country regulations, guidance documents, submission requirements, pharmacovigilance, drug labeling, and clarifying roles and responsibilities of key parties involved in initiating an Expanded Access or Compassionate Use program.
MedaSystems builds software that helps pharmaceutical manufacturers handle requests for Expanded Access. We offer a modern SaaS platform for submitting, receiving, and managing Expanded Access cases, in compliance with information security regulations such as HIPAA and 21 CFR Part 11. The platform enables timely and effective decision-making, with lower administrative overhead, real-time analytics, and an automatic case archive for audit purposes.