Explore our services

Clinical Supply

Extensive experience to manage
your global clinical trial supplies

CREAPHARM is your global partner for Clinical Trial Supply Management
(CTSM) specialized in clinical packaging, labeling and clinical logistics.
Benefit from a worldwide scope with local specialists to maximize the
success of your clinical trials!

Service overview

Sourcing
Investigational Products (IMP/IP)
Comparators
Auxiliary Medicinal Products
Ancillaries
Materials
Clinical Storage
Secure IMP storage
Secure DS/DP storage (bulks)
Clinical Packaging
& Blinding
Primary packaging
Secondary packaging
Clinical labeling
Blinding
Pharmaceutical
Certification
QA release
EU-QP release
Clinical Logistics
Worldwide clinical distribution
Direct To/From Patient
Returns & Destruction

Clinical supply chain management

Studies
Phase I to IV clinical trials, compassionate use (EAP)
Guidelines
GMP & GDP
(ANSM, ANSES)
Customers
Pharma, Biotechs,
Hospitals / Institutionals
Locations
3
Distribution partners
+40

Clinical supply experts

Céline Tinguely

General Manager
& Qualified Person

Experienced in the pharmaceutical industry, Céline has worked in several companies bringing her industrial expertise from production, to packaging of products and pharmaceutical distribution. She joined CREAPHARM in November 2015 as Qualified Person and manage the commercial packaging activities. Since 2022, Céline has also been responsible for Clinical Trial Supply Management activities.

Laurine Jung

Qualified Person &
Deputy General Manager

The complementarity of our QA experts is a key factor to meet the requirements of all players. I have three words: rigour, agility, and dynamism!

Alexia Blandino

Project Department
Manager

With an extensive experience in project management and CDMO environment, Alexia is leading the project team. She is the first escalation point of contact for our customers and has a major role in the organization as the conductor of most of the site activities.

Louis Ducongé

Plant Manager
CREAPHARM Le Haillan

With a Master’s degree in industrial management, Louis Ducongé brings to the team his 7+ years’ experience in both pharmaceutical and medical device industries. His Lean/6-Sigma certification helps the organization to strive for operational Excellence and Quality.

Pierre Menozzi

Plant Manager & Delegated Pharmacist
CREAPHARM Reims

Pierre has carried out a wide variety of assignments during his career as an Industrial Pharmacist. These different experiences have enabled him to acquire knowledge of industrial production processes. Since 2021, he oversees all the Clinical Trial Supply Management Reims’ team.

Marine Thiebaud

Plant Manager
CREAPHARM USA

Since 2022, Marine has been managing CREAPHARM USA in Marietta, GA. With a Master’s degree in Quality Management and experience in temperature-controlled products, she aims to optimizing pharmaceutical distribution processes to meet the needs of our clients.

Charles Cros

Production Manager
CREAPHARM Le Haillan

Charles spent the last 5 years in various highly regulated industries, with different roles around production and maintenance management. He is leveraging all CREAPHARM operational strengths to improve quality, efficiency & responsiveness.

Christel Rivoallon

Logistics, Warehouse and Production Department
CREAPHARM Reims

Christel has more than 20 years of experience at CREAPHARM and supervises Logistics, Warehouse & Production Department. She is the guarantor of the continuous improvement and the conformity of the production processes.

Ludovic Camus

Logistics Manager
CREAPHARM Le Haillan

With a Master's degree in Logistics, Ludovic has held the positions of Supply Engineer, Logistics Project Manager and Operational Logistics APU Manager which allow him to manage teams and steer activities in the performance and optimization of our distribution processes, in compliance with our continuous improvement approach and safety procedures.

Sebastien Terrier

Depots
Manager

With 23 years of experience within CREAPHARM, Sebastien sets up and coordinates the activities of depots and international shipments by best combining the needs of the client, local specificities and regulatory obligations.

Elodie Soulié

Head of
QA

Elodie has a Master's degree in Quality Management and 20 years of experience at CREAPHARM and supervises Quality System Department. She is in charge of harmonizing practices on the different plants within CREAPHARM CLINICAL SUPPLIES in compliance with both regulations and our continuous improvement procedures.

Why Trust CREAPHARM?

Quality

In compliance with the standards, we guarantee full traceability of all the operations contracted to us. Being uncompromising on the quality of our services and fully mastering each step of our production chain is our absolute priority and one of the CREAPHARM’s strong commitments.

Accreditations & certification

Reims

French Public Health Agency (ANSM) approved
Manufacturer’s authorization
GMP certificate
GDP authorization
Certificate of GDP compliance of a Wholesale Distributor

Le Haillan

French Public Health Agency (ANSM) approved
Manufacturer’s authorization
GMP certificate
GDP authorization
Certificate of GDP compliance of a Wholesale Distributor

Marietta

Board of Pharmacy approved
Wholesaler license

Traceability & Quality Management System (QMS)

Quality is at the heart of our concerns, with full-traceability as a priority. The fundamentals of data integrity are applied to each step. The reliability of our processes is continuously evaluated at CREAPHARM. To support Quality, CREAPHARM has invested in cutting-edge technologies.

Quality culture

Beyond the quality of products, we place a particular importance on the quality of our relationship. This is because we are attentive, and share our experiences daily, that we take responsibility for your project in the best conditions possible.

We believe it’s essential to establish a close partnership, based on trust and transparency.

A Clinical Supply Manager dedicated to your project

Supported by a team of experts


Clinical Supply Managers are the key project leaders. Each of your studies has a dedicated Clinical Supply Manager plus a back-up to assure continuity of progress.

During the set-up of a study, the Clinical Supply Manager ensures your specifications and timelines to meet First Patient In requirements. The whole team is focused on delivering the right product to the right patient on time.

Drawing on our experience in managing numerous clinical studies, we identify and implement the key success factors for the customer’s benefit. Clinical Supply Manager will provide tailored solutions to improve efficiency and reduce costs.

30 years of experience

Clinical Trials
Supported

3 000

Ongoing
Clinical Trials

900

Clinical Batches
Processed

15 000

Partners Depot
Worldwide

40

Shipments
Worldwide

300 000

Agility

As each study and protocol is different, our experienced team, equipment and processes will always adapt to client specific requirements, whether you’re going to conduct early or late-stage clinical studies.

We leave room for modifications and for the unexpected while managing your project. Daily, our teams are very responsive and agile in meeting the specific needs of each customer within the given time frame. CREAPHARM experts are able to propose the most appropriate solution for both packaging and clinical distribution.

Global Clinical Supply Management

In accordance with GMP/GDP standards

Our French and American Clinical Supply teams, together with our global depot network, manage your clinical trial material with
agility. Our 2 French pharmaceutical facilities in Reims and Le Haillan have the status of importer, manufacturer and distributor of
investigational medicines. The US facility in Marietta has a Wholesaler license and a Wholesale Pharmacy license allowing our site
to source commercial products on the U.S. market.

How can
CREAPHARM
support you?

Project Management

At CREAPHARM, the project is at the heart of our concerns. A dedicated project team takes in charge each challenge. The Clinical Supply Manager (CSM) is your dedicated contact: supported by a team of experts, the CSM coordinates operations.

With an international spectrum, CREAPHARM provides you with local specialists. Transparency and fluidity of exchanges both internally and with the client are key factors in the success of your clinical trial.

Clinical Packaging

That meet your clinical trial requirements

Primary packaging

Handling any clinical batch size

Blistering:capsules, tablets, softgel capsules and syringes
Bottling:capsules, tablets and softgel capsules
Highly potent packaging: a workshop dedicated to the packaging of highly potent products is available in Reims facilities. CREAPHARM has the pharmaceutical authorization for the primary packaging operations of highly active products such as hormones (substances with a hormonal activity), cytotoxics and highly potent products

Primary Packaging Suites

7

Blistering Production Lines

4

Bottling

Manual & semi-automated counting

Secondary packaging & Labeling

Patient-centric solutions

Tailor-made patient kit
design

Boxes, wallets, blister cards…

Packaging items
sourcing

Clinical labeling

Labeling texts in accordance with Annex 13 of EU GMP
Multilingual labeling & certified translation services
Innovative labeling solutions
GS1 standard for investigational drugs
Just-In-Time labeling

Specific conditions for
packaging/labeling

At room temperature, in cold room (+2°C/+8°C or -25°C/-15°C) or on dry ice to maintain product integrity
TOR (Time Out of Range) management
Packaging items adapted to temperature constraints

Secondary
Packaging Suites

18

Secondary Packaging Suites
Next to Cold Room

14

Blinding

The solution to your blinding challenge

Manufacturing of matching placebo
Over encapsulation
Masking
Randomization

Pharmaceutical Services

Extended support until release

Certification

EU-QP Release

Confirmation

Import Management

QA release (US)

BREXIT solution

Sourcing

A qualified and global network of suppliers

Supply of the product under test (Investigational Medicinal Product (IMP))
Purchase of other products for the clinical study, from France and abroad: comparators, Auxiliary Medicinal Products (AMPs), rescue medications, ancillaries
Purchase of the material required in the trial

Clinical Logistics

Guarantee of a secure GMP/GDP storage

Security, our common priority

GMP/GDP certified storage facilities
Power generator
On-site equipment back-up
Possible split on different warehouses
Insurance
Disaster recovery plan
24/7/365 monitoring

Global clinical distribution

Shipping treatments to patients

Entrust your logistics to a single specialist coordinator with a worldwide network: 3 facilities in France and USA and more than 40 depots all over the world. Thanks to many close and long-lasting partnerships, various carriers have been qualified to offer flexibility, meet deadlines and provide guarantees.

CREAPHARM offers express, premium or hybrid transport solutions.

The reliability of CREAPHARM and its partners is reflected in a rate of over 98% of deliveries on time and less than 1% of temperature excursions in 2021.

Shipments to sites or to one of our depots
Direct To/From Patient
Returns & destruction management
Import & custom clearance management
Interface with IRT
Online customer-access to stock situation

Temperature - controlled storage

Throughout the life cycle of your clinical trial drugs
2489
pallets
3218
shelves
+15°C / +25°C
235
pallets
1129
shelves
+2°C / +8°C
113m2
walk-in
freezers
-20°C
22
ultra-low
freezers
-80°C
80m2
NARCOTICS
*Evolving capabilities

Introducing

Myonex has reached an agreement to acquire Creapharm’s Clinical & Commercial Packaging and Bioservices Business