clinactis: logistics of asian based clinical trials

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - [email protected]

Logistics of Asian Based Clinical Trials

ClinActis is exclusively focused on Asia Pacific, with solid expertise in applying international quality standards to regional specificities. ClinActis is flexible in our approach to work scope and budgeting and contracting process. Delivering Quality to Our Clients ClinActis is committed to implementing international standards in clinical trials. Our ability to deliver high quality results to our clients is based on recruiting and maintaining the best talent within our organization. ClinActis’ senior management is fully accountable for the quality of deliverables to our clients.


Your Proactive Clinical Research Partner in Asia Pacific

ClinActis Pte Ltd is a full service CRO providing clinical trial services to the pharmaceutical, medical device, medical nutrition and biotech companies in Asia Pacific. Established in 2009, ClinActis Pte Ltd is headquartered in Singapore. ClinActis Value Proposition ClinActis is a multicultural company. As such, the team is able to communicate effectively with international clients.


Mission and Vision With headquarters based in Asia, all corporate

decisions are made within the region, in order to better anticipate our client needs and adapt to local specificities. Vision Our vision is to become the reference CRO specialized in conducting clinical research in Asia Pacific, offering state of the art quality services, with cost effective solutions. We strive to employ people with genuine expertise in the region and with a passion for excellence, to work with our clients in the most pro-active way, and to build a relationship based on trust, transparency and strong ethics. Mission

Our mission is to provide our clients with unique and dynamic expertise in applying global drug development standards to the specificities of each country in the Asia Pacific region.

Christophe Tournerie, MD – Owner and CEO Dr. Tournerie has more than 20 years experience in clinical research in Europe and Asia Pacific including Japan, working with biotechnology companies, pharmaceutical companies and clinical research organizations. After completion of his medical studies in Paris and various hospital assignments in France, Dr. Tournerie spent a period of 3 years at the National Medical Research Institute in France in the field of drug development in anti-HIV products.


About Our Founder

His introduction to the pharmaceutical industry was as Medical Director in an American biotechnology company developing anti-HIV products. Then, he moved to a large global CRO, heading the Project management Department for South Europe, and then as Head of Operations in the Japan affiliate. Later, Dr. Tournerie headed the Asian clinical research activity for a multi-national Pharmaceutical Company, based in Singapore. More recently, Dr. Tournerie was Vice President Asia Pacific for a large global CRO, based in Singapore. During this assignment, Dr. Tournerie developed the business strategy for the region, successfully established and directed operations in 12 countries and built a highly professional team.


Operational Expertise – Regional Footprint

ClinActis Experience §  33 years experience in clinical

research in pharmaceutical and biotechnology companies as well as CROs

§  27 years experience in Asia Pacific, including Australia/New Zealand, China, Malaysia, Hong Kong, India, Indonesia, the Philippines, Singapore, South Korea, Taiwan, Thailand, Japan and Vietnam

§  Extensive knowledge of regulatory frameworks, best KOLs and sites across the region

§  Vast therapeutic experience including Oncology, Infectious diseases, CNS, Cardiovascular, Endocrinology, and Respiratory


Importation of Drugs and Governing Bodies

Logistics One concern for sponsors is the importation and distribution of drugs and biologics into foreign countries. Dealing with customs and governing bodies can be challenging. ClinActis supports the shipment of drugs and biological samples through carefully planned and well managed procedures, especially for temperature and time-sensitive products. With local knowledge, use of specialist logistics providers (local agents to facilitate customs clearance), set up of regional distribution hub and careful selection of regional central laboratory, the risks involved in the movement of clinical trials materials will be mitigated.


Drugs

Centralized Drug Depot In general, the solution ClinActis would recommend is to set up a centralized drug depot in Asia with/without country specific drug depot. To better navigate global trade regulations, differences in customs requirements, and regulations, ClinActis works closely with international drug depots that have set up offices in Asia specifically for management of clinical trial logistics, eg: Zuellig, Fisher Clinical Services etc.

Singapore For centralized depot, Singapore is a good option not only due to its centralized geographical location but also the stringent and carefully monitored drug depots, with cGMP facilities. Such arrangement allows flexibility in drug movement to support active recruitment sites. Usage of tools such as IVRS and IWRS allow real-time monitoring of the recruitment and inventory levels at each site for better management of the drug supply vs demand, including expiry dates management.


Drugs (Continued)

Drug Management Nevertheless, country specific drug depots could also be a pragmatic solution to avoid potential delays with regulatory approvals. ClinActis will propose the best solution for drug management based on Sponsor’s requirement, our experience with the shippers and our local knowledge. ClinActis offers country specific solutions for country specific requirements. For example, in the Philippines, the Import License is site specific, valid for single

import only and expires in 6 months. Not only does ClinActis track the validity of the Import License, but also once the current Import License is used and we apply for a new License to ensure that a valid License is always available. In many countries, there are also strict requirements for importers i.e. the qualifications of importers and the type of company performing the import (Sponsor, Distributor or CRO). Customs regulations in these countries are also complex and are strictly adhered to by customs staff. Any issues with the shipment itself, or the accompanying paperwork, can result in materials being held in customs for prolonged periods. Working with ClinActis, who have up to date working knowledge of these intricacies, as well as careful forward planning will easily help Sponsors ensure the smooth running of a clinical trial.


Biological Samples Temperature Sensitive Biological samples are both time and temperature sensitive; temperature requirements can range from ambient to – 80 degrees Celsius and may sometimes need to be shipped to the central laboratory within 72 hours to maintain specimen integrity. Global shippers such as TNT, DHL, World Courier can assist with the packaging, providing packaging materials (eg: dry ice) and door to door shipment.

Regional central laboratories have also been set up in Asia Pacific: Lab Connect, Lab Corps, Quest Diagnostics etc. The use of regional central laboratory can reduce shipment time, shipment cost and even specimen processing time while adhering to global standards for the specimen analysis.


Biological Samples (Continued)

Real-Time Shipment Tracking To ensure that the specimens are seamlessly received by the laboratory, ClinActis can also assist sites with dummy specimen shipments to verify the transit time, ensure that the sites are well trained to pack and label the specimens, arrange the courier and complete the paperwork required. Not only that, ClinActis will monitor the real-time shipment of specimens to the central laboratory with the use of global

shippers’ tracking system. We could also arrange for International Air Transport Association (IATA) training for site personnel on-site. As Export License requirements differ from country to country throughout the region, ClinActis will share our local expertise and advise Sponsors on the most suitable countries and sites for trials with specific analysis requirements.


Clinical Sites Singapore Healthcare Infrastructure The infrastructure varies greatly between countries and even within each country itself. Singapore boasts one of the world’s best healthcare infrastructures, while in some second tier countries, certain provinces can be more advanced than others and when more sophisticated equipment is needed, they need to borrow from the better equipped hospitals. Nowadays in these countries overall advances in

technology and equipment are visible, even if the building appears less developed. The choice of site depends on the clinical study’s complexity, the logistics, standard of care and type of treatment, among other criteria. For a Phase I study where multiple PK sampling is required, or a complex oncology trial that needs sophisticated diagnostics equipment, a first tier country should generally be considered.


Clinical Sites (Continued)

GCP Certified Sites Second tier countries present advantages for where a large patient pool and less advanced equipment is needed, for certain therapeutic areas such as infectious and tropical diseases, or when the protocol requires treatment naïve patients. Although South East Asian countries are at different stages of development, significant advances are being made and the large increase in GCP certified sites have been established to support clinical research activities. Singapore, Malaysia and Korea’s governments, for example, have been taking an active role in investing and building local clinical research networks.


Investigators Motivated and Enthusiastic Asia has a large pool of well-educated, highly motivated and enthusiastic investigators, who have conducted their studies at well-reputed institutions in the US or Europe. In the majority of the countries it is the institution which is paid with a per patient fee, although in the Philippines this is a part institution/ part PI payment. Still, the main motivation is to work as part of international clinical trials, increasing their expertise and hopefully having their name in a

publication, as this will largely help moving forward with their academic career. Investigators are more conservative than in Western countries, so generally when they provide feasibility results there will be no great surprise when it comes to the recruitment rates of a study.


Patient Recruitment and Retention Asia’s High Ranking According to a 2012 Tufts CSDD report, clinical site activation rates in Asia Pacific are at one of the highest, with 91% of sites successfully progressing through the study start up stages and recruiting the first patients in at speed. Not only are site activation rates high but Investigative sites operating in this region achieved target enrollment levels at 107%, making it the top region in that respect. Despite these figures, with clinical research activities in the region

Growing and the increase of more complex protocols, it is necessary to emphasize the importance of focusing on Patient Recruitment. At site level this is being recognized, in Singapore for example, some sites now have in-house ‘recruitment teams’ to support these activities.


Recruitment and Retention (Continued)

Patient / Doctor Trust Across all Asian cultures, physicians are highly regarded and patients put their complete trust in their doctors creating an advantage for recruitment and maintaining low drop-out rates. In Asia more of an emphasis must be placed on the informed consent process, ensuring site staff are sufficiently trained in this area and are educating trial subjects early on.

On top of this, extra efforts need to be made ensuring participants feel involved for the trial duration. The 2013 CISCRP Perceptions and Insights study, on study participant experiences, showed that in Asia Pacific, the prospect of receiving clinical results and regular updates about research during the study were the top factors for influencing their decision to participate. A further study conducted showed that a significantly higher percentage of study participants in Asia Pacific were receiving updates on either a daily basis or at least a few times a week, compared to the US and Europe.


Recruitment and Retention (Continued)

Regional Success Factors Retention strategies are key to success in the region: §  Assigning a dedicated study coordinator to each trial

subject in order to create familiarity §  Including personal touches, such as birthday cards in

pediatric studies §  Building in efficiencies, for example, combining study visit

with other regular visits the patient needs to make §  Patient meetings, to create a sense of community and

allow to reinforce important messages §  Weekly phone calls

The same report showed a significantly higher proportion of Asia Pacific study participants rating free procedures, free study drug and their relationship with study staff as major motivators to stay in the study: 121%, 140% and 100% respectively more than their European counterparts.


Contact Us for More Information

Imen Jelassi, PharmD, MSc EU Director, Strategic Relations M: +33 6 28 11 13 71 E: [email protected]

Bill Van Nostrand Head of Business Development, North America M: +1 908-229-5220 E: [email protected]

clinactis: logistics of asian based clinical trials

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