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, Korea and Australia, as well as India through our strategic alliance with an Indian CRO.
1. ClinActis value proposition
ClinActis is a multicultural company. As such, the team is able to communicate effectively with interna-
tional clients.
ClinActis is exclusively focused on Asia Pacific, with solid expertise in applying international quality stan-
dards 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.
Your proactive
clinical research
partner 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 us
Clinactis Pte Ltd
112 Robinson Road
#06-04
Singapore 068902
Telephone: +65 64365500
Fax: +65 64385941
info@clinactis.com
www.clinactis.com
2. 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