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.

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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

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

“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.”