What We Do

Big Leap Clinical Research Support Joint Stock Company (or “Big Leap Research”) is one of the first local Contracted Research Organizations (CROs) in Vietnam with built-in capacity to provide clinical research supporting and site management services.

With our expertise and extensive network in Vietnam Clinical Trials Industry, Big Leap Research has provided clinical research supporting – consulting services to a multitude of global and local pharmaceutical companies, biotechnology companies, medical device companies and other CROs. As of January 2019, we have managed over 40 clinical research studies in 12 different therapeutic areas across 36 major hospitals throughout Vietnam. Our project portfolio mainly consists of multi-national, multi-institutional studies in Oncology, Pulmonary, Cardiovascular and Infectious diseases.

At Big Leap Research, we are committed to provide you the best Quality of Service every step of the way: feasibility assessment, regulatory submission, site negotiation, clinical research site supporting, monitoring and project management. As your partner, we will support you throughout the entire process and help you attain the desired outcomes for your clinical research trials in Vietnam.

SERVICES


At Big Leap Research, we offer a comprehensive range of CRO Services to meet all demands of your clinical trial: feasibility assessment, regulatory consultation and submission, study site negotiation, clinical research monitoring, project management... Additionally, through our Site Support Department, which operates independently, we also have the capacity to provide data entry and administrative supporting services at the hospital study site.

ORGANIZATION


Big Leap Research's Services are independently provided through our Clinical Operation Department (COD) and Site Support Department (SSD). Our COD Department provides CRO services through Clinical Research Associate (CRA), Clinical Trial Assistant (CTA), Line Manager (LM) and Project Manager (PM). Our SSD Department provides SMO services with data entry and site administrative support through our Clinical Research Coordinators (CRCs).

NETWORK


Big Leap Research has a good reputation within Vietnam Clinical Trials Industry. We have worked with many top companies and organizations in Vietnam over the past 4 years, and our network has grown extensively. We are currently working with 36 major hospitals in Vietnam, including: 16 hospitals in Hanoi, 15 hospitals in Ho Chi Minh City, 1 hospital in Hue, 1 hospital in Danang, 1 hospital in Dong Nai, and 2 hospitals in Can Tho.

HISTORY


Big Leap Research was established in 2015 as a Site Management Organization (SMO) with only 12 employees. In 2016, we obtained our Contract Research Organization (CRO) license, established our Headquarter in Ho Chi Minh City and opened a Branch Office in Hanoi. We received our ISO 9001:2015 certificate for Clinical Trial Supporting Activities in early 2017 and expanded our capacity to a Joint Stock Company with over 50 employees in 2018.

EXPERTISE


From 2015 until now, Big Leap Research has managed over 40 clinical research trials in 36 major Vietnamese hospitals, the majority of which are multinational, multi-institutional clinical trials. We have experience and expertise in the following Therapeutic Areas: Oncology, Pulmonology & Respiratory, Cardiology, Endocrinology, Infectious Diseases, Nephrology, Neurology, Ophthalmology, Immunology, Hepatology and Orthopedics.

CLIENTS


Since 2015, Big Leap Research has provided clinical research consulting - supporting - management services to a very diverse range of clients, both locally and globally. Our clients include Pharmaceutical companies, Biotechnology companies and Medical Device companies from Vietnam, Singapore, Korea, Japan, European countries, and USA. We also work with small and large companies within the Clinical Trials Industry in Vietnam, as well as many global CROs.