Expanded Access Program Services
Managing Unique and Urgent Demands
Expanded access program (EAP), early access, compassionate use, managed access program—different names for the same need—patients simply can’t wait for life-saving therapeutics. However, delivering investigational drug product outside the constructs of a clinical trial presents unique challenges.
Leverage CalCog’s extensive expanded access expertise for drug supply management services or comprehensive design and management of your expanded access program.
The Challenges of Expanded Access Programs
Clinical trials are complex but expanded access programs take these challenges to a new level. CalCog uses our experience to streamline a pathway through the often challenging expanded access landscape.
- Prescribing activity from physicians is sporadic and difficult to forecast
- Patient populations can be very small
- Drug supply requests are often time-sensitive
- Extensive coordination is required for distribution and logistics to reach patients globally
- Relabeling and/or repackaging are often required
- Regulatory requirements are demanding and regularly evolving
CalCog has over twenty years of experience designing and managing expanded access programs serving patients worldwide.
Global Expanded Access Program Management Capabilities
We understand the critical need to provide medication access to underserved patient populations globally and the requirements to be successful. For over twenty years, CalCog’s expertise has been supporting expanded access programs that aim to provide ethical continuation of therapy to patients and increase key opinion leader (KOL) engagement.
If you require extensive real-world data collection, pharmacovigilance, or reimbursed program support, CalCog is not your ideal partner. However, CalCog is the perfect fit if you need a partner for expanded access program design, drug supply management, and physician/site management services.
Program Strategy & Design
CalCog has over 20 years of experience designing and executing global expanded access programs. Our team is familiar with the evolving expanded access regulations in countries worldwide. Additionally, we offer ongoing oversight providing another essential layer of expertise and confidence that your expanded access program remains compliant.
Drug Supply Management
CalCog leverages its 27+ years of managing investigational drug supply, including packaging, labeling, storage, and distribution for global clinical trials, to provide best-in-class expanded access program drug supply management services. If you have the regulatory resources to support your Expanded Access Program but need drug supply management expertise, CalCog is your perfect partner.
- Two GMP facilities for packaging, labeling, and storage, plus a network of over 35+ global depots
- Same-day shipping options to help medication get to patients quicker
- Robust inventory management to ensure accuracy and prevent delays
- Import/export experts manage the details of moving medications worldwide, including transportation charges, documentation, importer of record services, customs clearance, duties, and taxes
- Regulatory review of label text and translations to any language as required for cohort submission
Physician & Site Management
If you need assistance developing physician awareness, physician program setup, or medication ordering, CalCog can help. Our experienced, multi-lingual physician management team are former clinical research associates (CRAs) with strong clinical operations backgrounds.
- Develop trusted relationships with physicians
- Effective management of physician access requests
- A highly personalized and collaborative approach
- Greater success compared to the “call center” models offered by other expanded access providers
Our Consultative, Collaborative Approach
“CalCog fully understands the importance of Expanded Access Programs and the benefit to patients. We pride ourselves in our ability to treat all our clients on an individual level, offering a dedicated team carefully curated and positioned to ensure seamless communication and results to our clients and their patients.
Our clients appreciate our commitment to offering a quality service that adapts quickly to changes that arise throughout the program.”
Client Services Manager, CalCog
Years of Expanded Access Program Experience
Physician Requests Fulfilled Annually
Countries with Active Expanded Access Programs Under Management
Physician & Patient Requests
Please complete an information request form to inquire about a specific program CalCog is supporting.
Please contact your physician or healthcare provider, who can contact CalCog regarding program availability.
Do You Need a Bespoke and Novel Approach to Expanded Access Program Management?
CalCog has over twenty years of experience designing and executing global expanded access programs, and we are here to help.