Alcura, a Cencora company, has over 30 years of experience in the clinical journey worldwide by offering tailor-made solutions at scale. We specialize in providing comprehensive support for every phase of your clinical trial journey.
Alcura’s strong reputation for meeting clinical trial needs and enabling global market access is the result of decades of successful international partnerships. We work with healthcare innovators and patients around the world to ensure therapies are safely and rigorously tested in every trial phase. Your patients and your products can benefit from the many advantages Alcura offers.
WE ARE PROUD TO SUPPORT:
CLINICAL RESEARCH ORGANIZATIONS (CROS)
MANUFACTURERS / SPONSORS
HEALTH PROFESSIONALS/ HEALTH INSURERS/ CLINICAL HEALTH FUNDING AGENCIES
PATIENTS
Our experience
Alcura has more than 30 years of experience supporting clinical trials
800+
AVERAGE SHIPMENTS PER MONTH
100+
INVESTIGATIONAL MEDICINAL PRODUCTS HANDLED
85
BULK SHIPMENTS EXPORTED WORLDWIDE FROM OUR EUROPEAN HUB
153+
STUDIES INITIATED WITH ALCURA IN THE PAST YEAR*
*Source: Alcura own data 2023.
1,950+
GLOBAL SITES RECEIVED CLINICAL SHIPMENTS
382
UNIQUE REFERENCES SOURCED
52
10,000+
COUNTRIES REACHED DEPOT TO SITE SHIPMENTS
Global presence
Alcura is a global provider of specialized clinical trial services, headquartered in Barcelona, Spain. Our support spans all continents. As part of the Cencora network, we leverage our extensive global resources while maintaining a deep understanding of local European regulations and market dynamics to help you stay compliant and competitive.
Our international reach allows us to help research teams, pharmaceutical companies and contract research organisations (CROs) ensure proper logistics for their clinical trials in various countries.
Alcura’s European hub built in 2021 and located in Barcelona (Spain) with capacities of:
Our clinical trials dedicated team in Spain delivers worldwide coordination and support, timely delivery of clinical trial medication to patients.
1,300
3,400
4,310
Alcura is part of the Cencora network. Cencora is a leading pharmaceutical solutions organization centered on improving the lives of people and animals everywhere.
$250+ billion
REVENUE
Growth aligned with our customers’ long-term success.
46,000+
TEAM MEMBERS
Diverse expertise all focused on improving global health.
72 SHELVES IN CHAMBER FROM -20ºC AND HANDLED AT SAME TEMPERATURE
4 ULTRAFREEZERS AT -80ºC
1,300+
GLOBAL LOCATIONS
Delivering a range of services to address specific local needs.
50+
COUNTRIES WITH A LOCAL PRESENCE
Growing knowledge of market-specific healthcare environments.
400 LITERS OF SPACE IN CRYOGENIC TANKS
Clinical trial solutions
SOURCING OF COMPARATORS, MEDICAL DEVICES AND ANCILLARIES
CLINICAL TRIAL SUPPLY MANAGEMENT PATIENT SUPPORT PROGRAMS (PSP)
Integrated solution
Bulk receipt
Gestión Importación
Import management
Recepción medicación a granel
SOURCING OF COMPARATORS, MEDICAL DEVICES AND ANCILLARIES
Recepción Almacén Proyectos Alcura
Primary packaging
Receipt at warehouse
Embalaje primario
Recepción Comparadores
Sourcing of medication or medical devices
CLINICAL TRIALS SUPPLY MANAGEMENT
Distribución Directa a cliente
Distribution
Embalaje secundario
Secondary packaging
PATIENT SUPPORT PROGRAMS (PSP)
We offer a fully-integrated solution for clinical trials, from the initial design stage, providing service and value throughout your journey to trial. Our team can support with the search, service and supply of medication or medical devices, clinical trial logistics management, as well as importation, packaging, storage, distribution, return and destruction.
Calidad
Almacenaje
Distribución Devoluciones
Soporte a domicilio
Patient support programs (PSP)
Entrega a domicilio
Destrucción
Atención telefónica
Sourcing of comparators, medical devices and ancillaries
Supply of medication and medical devices.
Comparator drug products are essential control medicines that demonstrate the effectiveness of new therapies, but procuring them can be complex.
Our comparator sourcing support includes comprehensive sourcing services for your clinical trial needs. Specializing in procuring comparator drugs and medical devices, we help ensure that you have the right materials at the right time.
1 Robust procurement strategies for efficient sourcing.
2
3
4
Direct communication with the manufacturer to ensure quality and availability.
Supply of products from the same batch for consistency.
Adjusted supply quantity for each phase to meet your evolving needs.
5 Support for short- and long-term clinical trials.
6 Cost and time reduction of supply.
7 Transport with specialized supervision for secure delivery.
Streamlined pharmaceutical sourcing support for clinical trials
• Multi-country global procurement, with local knowledge to help navigate regulatory requirements and restrictions.
• Access to a worldwide network for efficient local distribution.
• Decommission of medication (FMD) for compliant disposal.
• Sourcing directly from manufacturers to assure provenance, integrity, and custom manufacturing for different trial phases.
• Supporting the pharmaceutical sourcing by:
STRICT SUPPLIER AND CLINICAL SUPPLY CHAIN QUALIFICATION PROCESSES
TRACEABILITY, ACCOUNTABILITY, AND RECONCILIATION OF PRODUCTS
PRICING, AVAILABILITY, AND LEAD TIMES INSIGHT
INSPECTION PROCEDURES AND WITHDRAWAL OF PRODUCTS
SECURE SUPPLY FOR THE DURATION OF THE TRIAL AND PRODUCT SAMPLES AND DOCUMENTATION
OUR SOLUTIONS
Clinical trials supply management
Assessment of clinical trial design
Alcura supports more than 300 clinical trials per year. With our expertise, we can advise and support on:
• Reviewing project management and advising on future approaches.
• Approach to supply chain, manufacturing and distribution.
• Optimization of clinical trial design according to timeline and costs.
Importer of Record (IoR)
As your IoR, we handle all necessary documentation, customs clearance, and regulatory compliance activities to allow you to focus on your core research and development activities. We serve the following markets: Europe, USA, Asia and Africa.
Primary and secondary packaging
With a global network and end-to-end capabilities, we’re ready to serve as your contract manufacturing organization to package and release your drug batches for phase I-IV clinical trials.
PRIMARY PACKAGING
MANUFACTURING OF PLACEBO IN SOLID FORMS AUTOMATED COATING
OVERENCAPSULATION OF DRUGS FOR DOUBLE BLIND TRIALS
PACKAGING (BLISTERS, BOTTLES, VIALS, AMPOULES)
PACKAGINGLABORATORY KITS
BOTTLING OF SOLID FORMS
SPECIAL TEMPERATURE-CONTROLLED AREAS FOR PRIMARY PACKAGING
15 o C to 25 o C
Alcura can manufacture liquid forms of placebo stored between 2ºC using a U.S. partner.
Reception
Distribution
SECONDARY PACKAGING
DESIGNS OF VARIOUS TYPES OF LABELS (SIZE, LANGUAGES, BOOKLETS)
MANAGEMENT OF LABELING AND RELABELING
DESIGN AND PRODUCTION OF BOXES
ANCILLARY (BAGS, TUBES, THERMOMETERS, ETC)
TEMPERATURE FOR SECONDARY PACKAGING 15o C to 25o C 2o C to 8o C -20o C -80o C*
* Medication is labeled in a -20ºC room or 2ºC to 8ºC with dry ice
QP certification and quality control
Quality is our core focus, and our facilities are overseen by experienced pharmacists and operate under rigorous standard operating procedures (SOPs). We uphold a robust quality management system (QMS) certified to both ISO 9001:2015 and GMP standards.
Quality control
1
Once medication arrives in the EU, a QP release process must be completed. This is mandatory based on EU Regulation (GMP).
2 Batch testing of medication will be required when there is no mutual recognition agreement (MRA) between the manufacturing country and EU.
3
Once medication is released it can be distributed to sites (EU and/or non EU).
Storage and distribution of investigational medicinal products
STORAGE CAPACITIES
Special storage controlled areas for all types of IMP, commercial and medical devices:
CYTOSTATIC
CHEMICAL SYNTHESIS MEDICATION
Cell and Gene therapy management
We understand the unique challenges you face in bringing your advanced therapies to market. We specialize in comprehensive, tailored solutions for cell and gene therapies (CGTs) and advanced therapeutic medicinal products (ATMPs). We help you navigate development, manufacturing, and distribution hurdles so you can focus on your most important goal: delivering life-changing treatments to patients.
Our manufacturer’s importation authorization (MIA) enables seamless import and release from any global location, shipping in and out of Europe. We also provide specialized cryostorage capabilities to ensure your CGT’s safe and efficient journey to market.
Alcura is driven by versatility when understanding the client requirements offering an end-to-end service for these special therapies.
Cell and Gene therapy
Delivery of 99.91% of shipments on time and within range.
Review of supply chain roles and QPs for CGT declaration.
Regulatory advice in CGT landscape.
Batch certification of CGT products in EU.
IMPORT AND EXPORT
Import licence for CGT medicinal products.
Specialized GDP team for CGT services.
STORAGE AND MAINTENANCE
SECONDARY PACKAGING
RETURNS AND DESTRUCTION
Controlled storage of CGT.
All temperature ranges, including cryostorage.
Controlled secondary packaging of CGT following EU rules.
Capability to return and destroy according to applicable laws.
Warehouse management (global network)
ALCURA’S PRESENCE (OWNED AND OUTSOURCED)
NO LOCAL DEPOT
ALCURA’S CROSS-BORDER COVERAGE
CRYOGENIC STORAGE FACILITIES
CRYOGENIC STORAGE FACILITIES COMING SOON
North America Canada, USA (PLSD)
LATAM
Argentina, Colombia, Mexico, Chile, Brazil, Peru (PLSD)
Distribution capabilities
Distribution direct to site through our validated logistics partners. 1 2 3 4
Transport and delivery of products safely to clinical research sites, hospitals, health centers, pharmacy offices and patient homes all around the world.
Cold chain guaranteed through qualified active or passive packaging solutions.
Agreements with national and international courier companies.
Africa
Kenya, South Africa (LSD)
Europe
Spain – (European hub), Israel (PLSD) United Kingdom (SD) Georgia, Moldova, Russia, Serbia, Turkey, Ukraine, Lebanon (LSD) Returns management
Singapore (HUB), China, Australia, India, Japan, South Korea, Taiwan (PLSD)
management
POST-STUDY, WE MANAGE THE DESTRUCTION OF REMAINING STUDY MATERIALS:
Certified destruction of medication of special control, cytostatics and biological products. Inertization and incineration.
OUR SOLUTIONS
Patient Support Programs (PSP)
We are committed to supporting patients in managing and maintaining their health at home, helping to increase adherence to treatment.
PSPs improve the value proposition of drugs by offering value-added services both to patients and the healthcare system.
PSPs boost patient empowerment and support by reducing the stress of attending hospital, improving adherence.
WHAT ALCURA’S PROGRAMS OFFER
At Alcura, we design and develop programs to provide patient-based care at home to increase patient’s quality of life (eg. support on home infusion).
Coordination of the delivery of commercialized drugs from hospital to specialist centers. Support on the delivery of the IMP at patient’s home.
Pastoral support for patients, and coordination of services to ensure adherence to treatment. Pharmacovigilance services for adverse event notifications.
HOME CARE
HOME DELIVERY CALL CENTER
PSPs improve the value proposition of drugs by offering value-added services both to patients and the healthcare system.
Optimization of healthcare resources is another benefit of PSPs.
TRAINING AND COACHING
Development of training sessions for patients’ selfadministration of complex drugs. Training for nurses, and organization of awareness campaign events.
