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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 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 managing expanded access programs serving patients worldwide.

Global Expanded Access Drug Supply Management Capabilities

We understand the critical need to provide medication access to underserved patient populations globally and the requirements to be successful. CalCog leverages its nearly three decades 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 ideal partner.

  • Global network of over 35+ cGMP facilities for packaging, labeling, and storage
  • 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


expanded access program infographic - a pie chart in thirds, showing program strategy and design, drug supply management and physician and site management

Our Consultative, Collaborative Approach


Years of Expanded Access Program Experience


Physician Requests Fulfilled Annually


Countries with Active Expanded Access Programs Under Management


GMP Facilities

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 providing drug supply management for global expanded access programs, and we are here to help.