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CaligorRx.com
Global Access Programs
Bridging the GAP
Addressing unmet medical needs of patients
“With the advent of social media platforms,
global demand for access to medicines
is at an all-time high. Pharmaceutical and
Bridging the GAP
biotechnology companies must be prepared
to respond to physicians and patients. In an
effort to foster an ethical response, positive
publicity and ensure regulatory compliance,
companies may inquire as to what approach
they should take for these programs. Caligor
provides the answers to these questions by
effectively filling the access gap.”
MEDICATIONS
WITH LIMITED
ACCESSIBILITY
PATIENTS NEEDING
MEDICATIONS
I N T E R NAT I O N A L R E G U L AT I O N S
Providing physicians with access to medicines unavailable in their countries has revolutionized the way
in which pharmaceutical and biotech companies serve patients in need. These programs, called Global
Access Programs (GAP), can be complex given the dynamic regulatory environment, the unpredictability
of requests and the speed at which these medicines need to be delivered to patients. Caligor bridges
the gap between medicines with limited availability and patients in need using our innovative regulatory-compliant programs for drug access. Working alongside your team, we provide strategies to facilitate
optimal access throughout the product life cycle including the delivery of drug to sites into over 100
countries. Caligor GAPs can be implemented during various points in the lifecycle, such as:
• Still in clinical development but having sufficient safety / efficacy data
•A
s an optimal solution for patients exiting trials and / or in lieu of open label extension studies while
commercializing worldwide
• Where the medicine is licensed in one or more countries, but not in the patient’s country
Caligor GAPs are unique in that they are established on the basis of a clinical trial model but adapted
and customized to reflect the specific needs of an access program. Our approach uses validated clinical
trial e-tools and platforms that sponsors, physicians and sites have come to expect. Our “full-service”
approach allows companies to remain focused on the drug development process while we manage all
aspects of the program.
CaligorRx.com
Global Access Programs
“Our team understands the critical
For sponsors, the benefits of Global Access Programs are:
importance of strong and effective
• Controlled access and strong visibility of demand patterns
relationships with sponsors and
• First look at “real-world” data
sites, thus we only employ sea-
• Fostering of early relationships with physicians, patients and regulators
soned program operations team
• Increased product awareness / experience prior to launch
members with direct clinical trial
• Potential for revenue stream
experience.”
Caligor is uniquely qualified as your Global Access Program partner based on our
four pillars that support program success.
TEAM
TECHNOLOGY
LEADERSHIP
FULL-SE RVICE
BE ST-IN-IN DUSTRY
LEADERSHIP
Program Success
SEASONE D
PROGRAM MANAGEME NT
UN IQUE
IN NOVATIVE
FULL-SE RVICE
TECHNOLOGY
TEAM
PARTNE R
Our leadership consists of key individuals with many years of experience in this niche space and who
can strategically unlock the value of your access program. The full service approach allows companies to
“hand off” these critical programs to an expert so they can remain focused on the clinical development
and commercialization efforts. Caligor has implemented the latest e-tools and platforms that sponsors
and physicians recognize, allowing for ease of use and 24/7/365 accessibility. In addition, we only employ experienced program team members that have clinical trial experience and understand the nuances
of working with global sites, sponsors and their affiliates. Our programs also give visibility to real time
access to your real world data.
Another key to our success in delivering high value GAP medicines to sites around the world is our state
of the art facilities in both the US and the UK, enhanced by our worldwide strategic warehouse depots.
We partner with a range of speciality couriers to ensure there is a high touch element to transporting your
medicines to physicians and patients in need guaranteeing that there are no delays in delivery.
Caligor Rx Inc.
Caligor Rx Ltd.
801 Penhorn Avenue
No.4
Secaucus, NJ 07094
USA
Unit 23 Schooner Park
Schooner Court
Crossways Business Park
Dartford
Kent
DA2 6NW
United Kingdom
+1 212.988.0590
+44 (0) 1322 311 134
Planning for and establishing an access strategy with Caligor early in the product development cycle
offers companies the ability to understand demand and have the optimal provision and company position
for granting access throughout the lifecycle. By entrusting Caligor to manage your Global Access
Program, you can be assured that your program is being managed by a highly experienced team that
considers themselves an extension of your organization.
For more information about our Global Access Programs, please contact us at:
[email protected]