This document discusses the key logistical challenges of managing clinical trials in Africa and the importance of selecting a qualified logistics provider. Some of the main challenges include a lack of consistent infrastructure across countries, developing regulatory environments that vary between countries, and maintaining temperature control of shipments given Africa's climate and long transit times. It recommends choosing a single logistics provider with expertise in the specific African countries involved, demonstrated experience operating in Africa, and facilities to support the trial. Using a local distribution solution with in-country warehousing can help address many challenges and reduce risks.
Case Study: World's Largest COPD eCOA Trial Requires Reliability and Global S...CRF Health
CRF Health and its TrialMax® eCOA platform were adopted by a top 50 global pharmaceutical manufacturer to support one of the largest recorded phase III studies in chronic obstructive pulmonary disease (COPD). The trial, involving more than 19,000 patients in 35 countries, leveraged TrialMax® to deliver electronic versions of key COPD instruments, enabling investigators to monitor exacerbations while making compliance as easy as possible for patients.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Surgical Drains/Wound Drainage Market Bolstering the Demand during 2017 - 2025Arushi00
Surgical Drains/Wound Drainage Market is expected to boost due to the growing number of surgical procedures in various developing and developed regions; Surgical Drains/Wound Drainage Market in North America is projected to account for prominent revenue share
Dr. Pam Hullinger - Foot and Mouth Disease Continuity of Business Planning: C...John Blue
Foot and Mouth Disease Continuity of Business Planning: Current Focus and Progress to Date - Dr. Pam Hullinger, University of California, Davis Department of Veterinary Medicine & Epidemiology, from the 2012 Annual Conference of the National Institute for Animal Agriculture, March 26 - 29, Denver, CO, USA.
More presentations at: http://www.trufflemedia.com/agmedia/conference/2012-decreasing-resources-increasing-regulation-advance-animal-agriculture
Case Study: World's Largest COPD eCOA Trial Requires Reliability and Global S...CRF Health
CRF Health and its TrialMax® eCOA platform were adopted by a top 50 global pharmaceutical manufacturer to support one of the largest recorded phase III studies in chronic obstructive pulmonary disease (COPD). The trial, involving more than 19,000 patients in 35 countries, leveraged TrialMax® to deliver electronic versions of key COPD instruments, enabling investigators to monitor exacerbations while making compliance as easy as possible for patients.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Surgical Drains/Wound Drainage Market Bolstering the Demand during 2017 - 2025Arushi00
Surgical Drains/Wound Drainage Market is expected to boost due to the growing number of surgical procedures in various developing and developed regions; Surgical Drains/Wound Drainage Market in North America is projected to account for prominent revenue share
Dr. Pam Hullinger - Foot and Mouth Disease Continuity of Business Planning: C...John Blue
Foot and Mouth Disease Continuity of Business Planning: Current Focus and Progress to Date - Dr. Pam Hullinger, University of California, Davis Department of Veterinary Medicine & Epidemiology, from the 2012 Annual Conference of the National Institute for Animal Agriculture, March 26 - 29, Denver, CO, USA.
More presentations at: http://www.trufflemedia.com/agmedia/conference/2012-decreasing-resources-increasing-regulation-advance-animal-agriculture
LLA - A global provider of Logistics and Supply Chain TrainingPeter Jones CMILT
Education and skills development programs for those working in the Supply Chain sector. From introductory level through to the strategic and the technical skills to management and leadership
A presentation by Ms Simoné Smith (Senior Researcher: Transport, Freight and Logistics- CSIR), at the Transport Forum SIG: "Driving down cost in the Supply Chain" on 3 September 2015 in Durban, hosted by Transnet. The topic of the presentation was: "Cost of doing business through the ports".
The critical coordination of transport in less mature logistics environmentsTristan Wiggill
A presentation by Carsten Schubert, Director, Transnova, South Africa.
Delivered during the 38th annual SAPICS event for supply chain professionals in Sun City, South Africa.
In the last five years many South African manufacturers have accelerated their expansion plans into Africa but unfortunately often painfully and expensively. All too often the blame has been placed on the immaturity of local supply chains and poor levels of logistics maturity. But is this really fair? Even worse does this point to an ‘air of arrogance’ that South African companies believe they know better, an attitude that promotes the very resistance that they are seeking to avoid? In both a pragmatic and amusing presentation, filled with real-world anecdotes and personal experiences, the presenter will explore the challenges that face the South African logistician attempting to successfully penetrate the East African market.
PSFK Future of Retail 2015 Report - Summary PresentationPSFK
Get your copy of The Future of Retail 2015: www.psfk.com/report/future-of-retail-2015
In the fifth volume of the Future of Retail report the PSFK Labs team explores the dynamic social, technological, and physical forces influencing consumer behavior and driving next-generation shopping experiences. With a refocus on the importance of the physical store, our analysis below includes 10 in-store strategies supported by over a dozen key trends that retailers can use to immediately begin redefining their retail experience.
The report looks at how, in order to stand out from the competition, retailers and brands must make the best use of their customers’ time and attention by designing multichannel experiences that strike a perfect balance between efficiency and enjoyment, relevance and surprise.
Featured within the 110 page report, readers can find:
- 10 strategies to redefine the store
- Over a dozen global trends changing retail
- 20 future store concepts
- Perspectives from leading shopper experts across the globe
If you are interested in seeing a presentation of this report or would like to understand how PSFK can help your team ideate new possibilities for your brand, contact us at sales@psfk.com
Vol. 5 | Published November 2014
All rights reserved. No parts of this publication may be reproduced without the written permission of PSFK Labs.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
Innovative Hospital Partnership Model for High Quality Patient Clinical TrialsSGS
The biopharmaceutical industry has a growing need for patient trials, even in early phase, to support an early go-no go decision in compound development. Secured access to the patient population, a professional Clinical Pharmacology Unit environment with trained and experienced medical professionals, expertise in early phase project management and clinical operations are key factors for success.
To meet this industry demand, SGS has invested in SGS operated patient units located in hospital partners both in Belgium and Hungary. These centers are also used to build up further cooperation with neighboring early phase sites. SGS staff are involved in the qualification and tailor-made support of sites to achieve SGS quality and operational requirements.
This presentation will present how this partnership model works and why it is so beneficial for all parties.
For more information visit: https://www.sgs.com/exprimo and contact us at: clinicalresearch@sgs.com
Follow us on LinkedIn: https://www.linkedin.com/company/sgs
LLA - A global provider of Logistics and Supply Chain TrainingPeter Jones CMILT
Education and skills development programs for those working in the Supply Chain sector. From introductory level through to the strategic and the technical skills to management and leadership
A presentation by Ms Simoné Smith (Senior Researcher: Transport, Freight and Logistics- CSIR), at the Transport Forum SIG: "Driving down cost in the Supply Chain" on 3 September 2015 in Durban, hosted by Transnet. The topic of the presentation was: "Cost of doing business through the ports".
The critical coordination of transport in less mature logistics environmentsTristan Wiggill
A presentation by Carsten Schubert, Director, Transnova, South Africa.
Delivered during the 38th annual SAPICS event for supply chain professionals in Sun City, South Africa.
In the last five years many South African manufacturers have accelerated their expansion plans into Africa but unfortunately often painfully and expensively. All too often the blame has been placed on the immaturity of local supply chains and poor levels of logistics maturity. But is this really fair? Even worse does this point to an ‘air of arrogance’ that South African companies believe they know better, an attitude that promotes the very resistance that they are seeking to avoid? In both a pragmatic and amusing presentation, filled with real-world anecdotes and personal experiences, the presenter will explore the challenges that face the South African logistician attempting to successfully penetrate the East African market.
PSFK Future of Retail 2015 Report - Summary PresentationPSFK
Get your copy of The Future of Retail 2015: www.psfk.com/report/future-of-retail-2015
In the fifth volume of the Future of Retail report the PSFK Labs team explores the dynamic social, technological, and physical forces influencing consumer behavior and driving next-generation shopping experiences. With a refocus on the importance of the physical store, our analysis below includes 10 in-store strategies supported by over a dozen key trends that retailers can use to immediately begin redefining their retail experience.
The report looks at how, in order to stand out from the competition, retailers and brands must make the best use of their customers’ time and attention by designing multichannel experiences that strike a perfect balance between efficiency and enjoyment, relevance and surprise.
Featured within the 110 page report, readers can find:
- 10 strategies to redefine the store
- Over a dozen global trends changing retail
- 20 future store concepts
- Perspectives from leading shopper experts across the globe
If you are interested in seeing a presentation of this report or would like to understand how PSFK can help your team ideate new possibilities for your brand, contact us at sales@psfk.com
Vol. 5 | Published November 2014
All rights reserved. No parts of this publication may be reproduced without the written permission of PSFK Labs.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
Innovative Hospital Partnership Model for High Quality Patient Clinical TrialsSGS
The biopharmaceutical industry has a growing need for patient trials, even in early phase, to support an early go-no go decision in compound development. Secured access to the patient population, a professional Clinical Pharmacology Unit environment with trained and experienced medical professionals, expertise in early phase project management and clinical operations are key factors for success.
To meet this industry demand, SGS has invested in SGS operated patient units located in hospital partners both in Belgium and Hungary. These centers are also used to build up further cooperation with neighboring early phase sites. SGS staff are involved in the qualification and tailor-made support of sites to achieve SGS quality and operational requirements.
This presentation will present how this partnership model works and why it is so beneficial for all parties.
For more information visit: https://www.sgs.com/exprimo and contact us at: clinicalresearch@sgs.com
Follow us on LinkedIn: https://www.linkedin.com/company/sgs
The report features an extensive study of companies engaged in offering patient recruitment and retention services. The study features an in-depth analysis of the key drivers and trends related to this domain.
For more details, click here: https://www.rootsanalysis.com/reports/view_document/patient-recruitment-and-retention-services-market/245.html
Challenges and Opportunities for Digital PCR in the CLIA Laboratory of the Mo...Kate Barlow
Anthony Magliocco, Chair of Anatomical Pathology, Moffitt Cancer Center, USA
The Moffit Cancer Center is one of the largest NCI designated comprehensive free-standing cancer centers in the USA. The center has developed one of the most advanced personalized cancer medicine treatment programs in the world. This program is supported by a comprehensive and advanced CLIA molecular diagnostics. Digital PCR assays are currently being developed for several clinical applications including TKI resistance monitoring in patients with advanced lung cancer. The challenges and opportunities in deploying digital PCR into clinical practice will be discussed.
Pharmacovigilance in South Africa: Undocumented undergraduate training and pr...Jing Zang
Pharmacovigilance is a clinical discipline that is gaining more and more attention worldwide and in Africa. The rolling out of large scale programs on HIV/AIDS, tuberculosis and malaria has heightened the need to step up efforts to have pharmacovigilance concepts to be operationalized in clinical practice. A quick search in PubMed and Google Scholar and a review of available literature was conducted in order to establish whether medical, nursing and pharmacy undergraduate students are taught pharmacovigilance concepts and skills for effective practice. It seems that there is a paucity of data on the undergraduate training in pharmacovigilance in South Africa. It may be that there might be inadequate training on pharmacovigilance during undergraduate training of medical, nursing and pharmacy students in South Africa. More studies are needed to document the views and experiences of South African students and healthcare professionals on training and practice of pharmacovigilance.
''The Strategic Performance Index is a leader hip assessment measuring organizational success across key areas of growth, viability and sustainability''
The Internet of Things – Good, Bad or Just Plain Ugly?Yasmin AbdelAziz
The Internet of Things (IoT) is the network of physical objects—devices, vehicles, buildings and other items—embedded with electronics, software, sensors, and network connectivity that enables these objects to collect and exchange data.
Developing Emotional Intelligence for Healthcare LeadersYasmin AbdelAziz
Skills in emotional intelligence (EI) help healthcare leaders understand, engage and
motivate their team. They are essential for dealing well with conflict and creating workable
solutions to complex problems.
A Theoretical Framework (Modelling) for International Business ManagementYasmin AbdelAziz
The international framework with all the institutions and organisations
that determine country’s economic and support policy in emergent situations.
2. Impact of globalisation on international and national policy and activities. 3. The
national framework, which fairly complicated because there are many active players:
a) National economic policy: understanding it and the environment for trade
activities. b) National economic structure and competiveness of the domestic
companies. c) International management capacities. d) Local or regional environment
and conditions for the companies. e) Focus on the world market conditions and their
development
Securing the Global Pharmaceutical Supply Chain against the Threat of Counter...Yasmin AbdelAziz
In 2012, counterfeit versions of the cancer drug
Avastin were found in 19 American treatment
centers. The impostor drug lacked the active
ingredient, rendering it virtually useless for
treatment purposes.
The purpose of ALL is to deepen the
continent’s integration agenda and
renew commitment to a sustainable
path of growth and development
through access to African law and
governance.
How to Increase the Value of the PMMMs as a Business-oriented FrameworkYasmin AbdelAziz
An organization’s effectiveness partly depends
on the success of its projects. With this in mind, many
efforts have been spent in recent decades to enhance the
project management culture, but results are still highly
unsatisfactory. Project Management Maturity Models
(PMMMs) are seen by both the academic and the
industrial communities as a solid instrument to achieve
this goal. The point at issue is that surveys and researches
show PMMMs must be better linked to business and
financial performance. The aim of this paper is to explore
the scope for improvement to evolve PMMMs as
business-oriented frameworks.
1. Clinical Trial Logistics in Africa:
Ensuring Quality, Compliance and Control
within the Pharmaceutical Supply Chain
World Courier
May 2012
2. WORLD COURIER is the market leader in the handling, transport, storage and
distribution of temperature-sensitive pharmaceutical products and biological specimens
in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply
chain system, strong knowledge of the local regulatory environment, well-trained staff
and expert access to key African nations.
Since 2005, WORLD COURIER’s breakthrough Clinical Trial Supply Chain Services
(CTSCS) division has revolutionized the way clinical trial materials and samples are
managed in emerging nations. Operating the world’s largest network of GMP-compliant
investigational drug storage facilities, global capacity for WORLD COURIER’s 13 depots
now exceeds 235,000 square feet and includes a facility in Johannesburg (South Africa).
WORLD COURIER has operated company-owned offices in South Africa since 1980.
Africa is the world’s second largest and second most populous continent
after Asia, covering six percent of the earth’s total surface. With over one billion people, it
accounts for almost 15 percent of the world’s population.
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers
drawn to the study and control of both communicable diseases such as malaria, tuberculosis and
HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and
chronic respiratory disease.
With its unique geographies of clear therapeutic specializations, a growing presence of accredited
labs and qualified CROs especially in South Africa, relative ease of access to large treatment-
naïve populations, proximity to Europe and generally favorable exchange rates, Africa offers
sponsors great opportunity for conducting competitive low-cost clinical trials − assuming the
logistics can be appropriately managed. According to the U.S. National Institutes of Health, more
than 2,700 clinical trials are currently underway in Africa 1, a number that continues to increase.
1 www.clinicaltrials.gov,(April 2012)
3. Critical Mass in South and East Central Africa
In terms of drug discovery and development, South Africa leads the way. Of the approximately
2,700 clinical trials now being conducted in Africa, 1,441 or 53 percent take place in South Africa 2.
Boasting a first-class research infrastructure that meets FDA and ICH (International Conference
on Harmonization) standards, experienced investigators trained to EU/U.S. standards, a rapidly
growing number of accredited labs and qualified CROs, a strong IT infrastructure that produces
consistent quality data, wide public awareness of clinical trials, ease of patient recruitment,
predominance of the English language and the country’s geographical position as a major
gateway to the rest of Africa, South Africa leads the industry continent-wide.
Over 700 more studies are currently hosted in the 13 countries that extend northward from South
Africa through east central Africa − Uganda (183 studies), Kenya (162), Tanzania (133), Malawi
(86), Zambia (73), Zimbabwe (46), Ethiopia (38), Botswana (38), Mozambique (28), Rwanda (28),
Madagascar (8), Burundi (3), Swaziland (1) and Lesotho (1). Together with South Africa, these
countries account for over 83 percent of the continent’s clinical trial market 3.
What should you, as a pharmaceutical professional, know about the logistics of managing clinical
trials in Africa?
A Land of Contradictions
Despite the obvious attractions, today’s Africa can present a bewildering paradox to those who
are unfamiliar with its history and culture, and an unforgiving operating environment for the
uninitiated.
Images of emerging democracies, an abundance of natural resources, World Cup fever, a thriving
drug discovery environment and modern, cosmopolitan cities like Johannesburg, Nairobi, Cairo
and Casablanca are countered by large under-developed rural areas and developing social and
regulatory systems. Opportunity, on one hand, wrestles with challenge on the other, making Africa
a true testing ground for pharmaceutical companies and clinical trial professionals endeavoring to
do business here. Given the structure and multi-site design of today’s typical study along with an
increasingly stringent call for regulatory compliance, success in Africa effectively requires bio-
practitioners to bridge both worlds without slipping into the void.
But how can this be accomplished when clinical products and samples must routinely travel
thousands of miles over extended periods of time between the production floor, central labs and
individual investigator sites? Ultimately the answer lies in creating a solid logistics plan in
2 Ibid.
3 Ibid.
4. conjunction with a responsible local partner who is able to successfully manage all non-laboratory
and non-clinical aspects of the trial.
Here, then, are the key transport and logistical challenges to be faced when undertaking clinical
trials in Africa − challenges that can significantly drive up the cost of a study if not managed
effectively in terms of out-of-spec temperature ranges, limited product stability, potential for
missed dosings, unnecessary regulatory review, misuse of researchers’ time and questionable
research results:
• Infrastructure & Expertise
Unlike other continents where infrastructure and human capital capabilities remain fairly
consistent across most countries, there is a huge range in local facilities, experience, expertise
and aptitude across Africa − and even within individual countries − which can make doing
business here all the more challenging. A clear understanding of the local infrastructure,
resources and service capabilities in critical countries and site locations can help lessen
uncertainty before the trial begins.
• Developing Regulatory Environment
Like most emerging areas throughout the world, the regulatory environment in Africa is evolving.
With this evolution comes complexity, lack of clarity and import and regulatory procedures that
can vary significantly from country to country. With 52 distinct nations, Africa is no exception and
shippers should understand the regulatory requirements of each country that will host any part of
the study and factor in lengthy permit and importation timelines into patient dosing schedules.
In South Africa, for instance, there are four different regulatory agencies that may weigh in on
shipments entering and leaving the country: the Medicines Control Council (MCC), the Ministry of
Health, the South African Pharmacy Council and the South African Veterinary Council.
Pharmaceutical shippers will require MCC import permits, customs invoices, health certificates,
VAT-exempt certificates and veterinary import certificates for IPs containing animal material. The
need for extensive paperwork creates a somewhat cumbersome import process that, without a
strong local presence, can be slowed down by potential documentation errors.
• Variability of Local Service Providers
The complexity of the clinical supply chain presents a challenging distribution environment for
researchers who must ship large volumes of temperature-sensitive patient kits worldwide,
juggling their need to safeguard product quality and chain of custody with a continuous stream of
arms-length exchanges between local service providers. If the primary logistics supplier does not
have a well established network and a broad continental reach, shippers may experience an
5. undesirable variability among third-party contractors that can quickly compromise the in-country
handling of product and lab samples.
• Climate
Almost perfectly centered over the equator, Africa’s climate is classified as tropical, with Celsius
temperatures typically ranging in the 20s to 30s or higher. Temperatures can vary dramatically
from country to country depending on the season and can include searing heat, monsoon-type
rain, arid dryness and even snow in the mountain regions of Morocco and South Africa. Given the
limited number of direct flights from major international points to secondary African cities and the
often lengthy transit times from origin to destination, ensuring the stability of delicate temperature-
sensitive consignments can represent an enormous undertaking.
• Cold Chain Management
Managing temperature-controlled shipments effectively presents a key challenge in Africa.
Extreme temperatures combined with long transit times require the availability of refrigeration
facilities and supplies as well as trained personnel to handle them at all key junctures en route.
The availability of refrigeration units, the potential for power failures and the local unavailability of
appropriate packaging and dry ice in some locations − both for the inbound replenishment of
product refrigerants and the outbound temperature control of samples − demand sufficient
volumes, adequate oversight and innovative solutions from transport suppliers if quality is to
maintained.
• Under-developed Geography
Once a clinical trial gets under way and patient recruitment begins in earnest, the primary
concern of the clinical team is ensuring that the correct medications are supplied to each site and
each patient on time and within specification. Multiple sites, hundreds of patients and months of
testing add a complexity and risk for error that are intensified in emerging markets like Africa.
With road and transportation systems that may not be well developed outside of main cities,
consideration must be given to the reliability of in-country distribution capabilities for multi-site
studies and, if necessary, other solutions sought.
Choose a Qualified Logistics Provider
Generally speaking, the success of a logistics provider over the life of a clinical trial in Africa can
be measured by its consistent ability deliver expertise, strong internal controls and required
infrastructure when and where it is needed. The crucial first step for the pharmaceutical
practitioner lies in selecting, whenever possible, a single, fully-integrated, GxP-compliant service
provider with demonstrated effectiveness in the chosen market(s).
6. By employing the services of such an organization, on-the-ground responsibility is effectively
transferred to an experienced and trusted partner with the knowledge and internal operation to
support the clinical trial. By choosing a single provider and reducing the number of third-party
suppliers, the potential for miscommunication, misstep and error is also reduced.
• Service Provider Checklist
In order to optimize the chance for success, the following questions should be asked of any
prospective service provider:
• does the company exhibit expert knowledge of the regulatory environments of all
countries involved with the study, not just in selected geographies?
• does it keep abreast of current industry happenings? is it a member of relevant industry
associations such as the South Africa Clinical Research Association (SACRA) and the
South African Pharmaceutical Research Association (SAPRA), for instance?
• how long has the company operated in the specific study locations?
• does the company have a firm understanding of the realities of operating in Africa (i.e.
work environment, standards, challenges, pace)? does it have a proven track record?
• are staff and operatives appropriately trained to manage DG Class 6.2 (infectious
specimens), Class 9 (dry ice) and other types of cold chain shipments as required?
• what types of physical facilities (offices, warehousing, refrigeration, etc.) are available in
key site locations? how will study requirements be met if specific facilities are not
available?
• is every shipment routed with the primary goal of minimizing transit time or are they
consolidated in company hubs to minimize expense?
• how is operational guidance, technical assistance and quality oversight handled at the
local level?
• is a system in place to effectively manage communications between site personnel,
sponsor and research partners, the service provider and his local representatives?
• how confident are you that the organization can deliver what it promises, consistently
and without fail?
7. Utilize a Local Distribution Solution
In challenging locations like Africa, a local distribution solution can offer many benefits to both
sponsors and site personnel.
To reduce risk and maximize the control of delicate, temperature-sensitive IMPs, pharmaceutical
shippers should consider consolidating smaller international shipments into larger batch
shipments and utilizing an in-country warehousing solution. Once the bulk shipment has arrived
in-country, the distribution of patient kits to local investigator sites can be undertaken from a
secure, temperature-controlled local facility according to a pre-determined schedule and within
the confines of a secured timeline.
By utilizing a local warehousing solution, pharmaceutical shippers can reduce the occurrence of −
or even remove entirely − many of the “unknowns” that typically occur when shipping to
developing markets while realizing many quantifiable benefits:
• consolidated bulk deliveries will significantly reduce clearance costs
• the potential for customs and airline delays are substantially reduced by a decreased
import frequency
• a successful one-time in-country customs clearance removes unnecessarily repetitive
bureaucratic uncertainty and red tape, and with it, the possibility of regulatory delays
• with a larger clinical supply being maintained in-country, the potential for missed dosings
due to lack of supply is reduced or eliminated entirely by slightly overlapping bulk
importations
• transport costs will likely be significantly reduced, even while taking into account the
related warehousing costs
• product stability is ensured with improved control of the clinical supply in local
temperature-controlled purpose-built facilities once the shipment has cleared customs
• the fewer the shipments, the more time that is freed up for the clinical team who must
coordinate transport and distribution
• the shipper can benefit from local representation, local language skills and local time
zones should interface with local site personnel be required
Conclusion
Transportation and logistics services in Africa, like everywhere else, are fraught with unreliable
third-party contractors and untrained domestic service providers. In the area of clinical trials,
however, the stakes are particularly high. It is crucial, therefore, that research professionals are
able to rely fully on their local service provider to manage temperature-sensitive shipments
according to international regulatory standards and at the same operational level found elsewhere
in the world.
8. Choosing the right partner and taking advantage of alternate solutions such as local warehousing
and distribution will reduce uncertainty and bring knowledge, clarity, stability and international
standards to a complex situation. At the same time, it will help sponsors better manage risk and
improve their confidence and expectation levels.
www.worldcourier.com
May 2012