ClinActis value proposition

ClinActis is a multicultural company. As such, the team is able to communicate e�ectively with interna-tional clients.ClinActis is exclusively focused on Asia Paci�c, with solid expertise in applying international quality stan-dards to regional speci�cities.ClinActis is �exible in our approach to work scope and budgeting / 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 besttalent within our organization.ClinActis’ senior management is fully accountable for the quality of deliverables to our clients.

Providing cost effective solutions

ClinActis is able to provide fair and cost e�ective solutions to our clients.As a regional CRO, we have a streamlined but e�ective organization which minimizes overheads and we are able to implement country -speci�c rates. These translate to cost savings to our clients.Our knowledge of the region allows us to provide realistic and reasonable budgets upfront to our cli-ents and minimize subsequent budget changes during the study.

Your proactiveclinical researchpartner in Asia Pacific

ClinActis value proposition

ClinActis is a multicultural company. As such, the team is able to communicate effectively with international clients.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 / 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.

Providing cost effective solutions

ClinActis is able to provide fair and cost effective solutions to our clients.As a regional CRO, we have a streamlined but effective organization which minimizes overheads and we are able to implement country-specific rates. These translate to cost savings to our clients.Our knowledge of the region allows us to provide realistic and reasonable budgets upfront to our clients and minimize subsequent budget changes during the study.

Contact usClinactis Pte Ltd 112 Robinson Road#06-04Singapore 068902 Telephone: +65 64365500 Fax: +65 64385941 info@clinactis.com

www.clinactis.com

Clinical research in Asia Pacific

Asia Pacific, the growth force

The pharmaceutical market in Asia is growing at 10-15% in Asia compared to 5-7% in G7 countries (source: Price Waterhouse Coopers).

Good clinical trial infrastructure

There is continuous growth in the scientific base and capabilities in Asia, encouraged by local authorities, given the growing contribution of clinical research to the local economy.There are centralized healthcare institutions, well qualified, highly motivated investigators and excellent clinical trial facilities.Trials are supported by clinical trial units and study coordinators.

Efficient regulatory and ethics committee processes

With the appropriate approach, the regulatory approval processes in most Asia is no more complex than in the US or Europe, with the exception of China.The trend is towards reduction of regulatory approval timelines.Regulatory agencies countries are well organized and provide clear instructions on their processes and requirements for documentation. The majority of healthcare institutions have well organized Ethics Committees (EC) / Institutional Review Boards (IRBs) which follow ICH GCP and have now acquired significant experience.

ICH GCP as the only standard

Many countries adhere to ICH GCP in their processes for EC committee submission and regulatory approval.Since 1995, clinical trials in Asia have been predominantly for FDA/EMEA submissions.

Faster patient recruitment and good retention

Asia offers a large and diverse patient pool, with nearly 60% of the world population. US/EU treatment guidelines are followed in the treatment of disease.There is a large treatment naïve population, with diseases of both developed and developing world. Doctor-patient relationship is strong thus securing good patient retention by sites.There are still fewer competing trials compared to the West.

Cost benefits

Including investigator sites in Asia can help reduce the overall drug development timelines, with a higher number of patients in fewer sites enabling faster patient recruitment.Salary and out of pockets costs are still favorable when compared to Western countries.

IP protection

IP protection in Asia remains an issue when compared to Western standards. However, there has been significant progress in some key Asian countries to enforce IP protection and implement patent laws.

Logistics

Strategies to deal with the specificities of logistics in Asia include building local knowledge of regulations and import procedures related to clinical trials, as well as designing an adequate distribution approach, together with third parties.

Company Overview

ClinActis Pte Ltd is a Clinical Research Organization specialized in Asia Pacific, providing pharmaceutical, medical device, medical nutrition and biotech companies with state of the art clinical research services with an approach fully customized to the specificities of Asia Pacific.

Our regional coverage includes Singapore, Malaysia, Thailand, The Philippines, Vietnam, Indonesia, Taiwan, Hong Kong and Korea, as well as India through our strategic alliance with an Indian CRO.

ClinActis experience

32 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 and Japan

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

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

ClinActis services

ClinActis provides full-service solutions to support our clients with their Phase I - Phase IV clinical trials in Asia Pacific:

Consultancy on product development strategy

Feasibility studies and site selection, regulatory submissions, site start-up

Clinical project management

Site management

Clinical monitoring

Clinical research and ICH GCP training

Temporary clinical staffing

Data management, biostatistics and medical writing through our Indian partner CRO