Early access programs (EAPs) are initiatives that provide patients with access to investigational therapies before they become commercially available.
These programs, also known as post-trial access or compassionate use programs, allow clinical trial patients to receive continued treatment after the study has ended (Extended Access Programs). EAPs can also help patients that did not participate in the study, but under certain circumstances can receive the investigational therapy until the IMP (Investigational Medicinal Product) receives regulatory approval (Expanded Access Programs).
OUR ADDED VALUE THROUGH EARLY ACCESS PROGRAMS
Expertise
and Experience
Deep understanding of regulatory requirements, market dynamics, and challenges specific to Early Access Programs. Our experience can help streamline the process.
Accelerated
Timelines
We develop systems that allow pharmaceutical companies to supply their innovative products to patients in life-threatening situations, whilst the regulatory process takes place, potentially allowing patients to access life-saving treatments more quickly.
Regulatory
Compliance
We are well-versed in regulatory affairs and can help navigate the complex regulatory landscape, ensuring that the program complies with all necessary regulations and requirements.
Risk
Mitigation
We can help identify and mitigate potential risks, such as adverse events or regulatory setbacks by working closely with your clinical operations teams.
Data
Management
We can help collect and manage valuable data from Early Access Programs, such as Real World Evidence (RWE) data, which can be used for further research and development or to support regulatory submissions.
Quality
Assurance
We can implement robust quality control processes to ensure that the treatments provided through Early Access Programs meet the highest quality standards.
Global
Reach
We have a global presence and can assist in expanding Early Access Programs to different regions, enhancing the reach and impact of the program.
ADDITIONAL SUPPORT SERVICES
Pharmacovigilance : Ongoing monitoring of the safety of the drug with a robust system to report adverse events, analyze data, and implement risk management strategies.
Patient Support Programs : Development of programs to support patients post-registration, which may include educational resources, adherence programs, and ongoing health monitoring.
Real-World Evidence Generation : Collection and analysis of real-world data post-launch to support further regulatory filings and market positioning. This can include observational studies, patient registries, and other post-marketing surveillance data.
Renewal and Variation Management : Handling the submission of necessary documentation for renewals, variations, or extensions of the drug’s market approval.
By providing these services, companies support pharmaceutical industry clients through the entire lifecycle of a drug, from managed access to full market introduction and beyond, ensuring both compliance and effectiveness of the therapy provided to patients.
Send Us An Enquiry
To learn more about how we can improve your early access programs experience or receive a quote, please feel free to get in touch.