During the last two decades, Asia has become home to the world’s fastest emerging economies and the most challenging market in the world. It is crucial for CROs in important emerging markets to determine the current market landscape regarding the use of each service; understand customers’ needs and wants; understand perceptions regarding the CRO’s service capabilities versus other service providers and obtain reactions to each service concept, including likes and dislikes. Site management involves understanding the needs for global biopharmaceutical and device companies and setting realistic expectations with regard to the suitability of the protocol/ study design, number of patients that can be enrolled over a period of time and ensuring protection of the participants. Site management also involves assisting global companies navigate the complex operating environment for clinical research and takes the day to day operational burden off investigators so that they can focus on the patient care, and ensure that the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of high quality study data necessary for global regulatory and product approval submissions. Site support model involves placement of a full-time, highly qualified clinical research coordinator (CRC) at each study site to assist the investigators and site staff with all day-today study conduct activities. The primary focus at the site is to ensure patient protection, protocol compliance by ensuring enrolment of appropriate patients. Coordinators are trained to provide professional assistance to the investigator to ensure compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks.

Patient recruitment and retention are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimise both you have to have a plan. The potential benefits of an SMO are well known: rapid and reliable patient recruitment, improved data quality and consistency, reduced study timelines primarily due to quicker study start-up, more accurate doctor contact information, reduced site management time, improved relationships with investigators.

Despite the development of an impressive array of recruitment tactics over the last decade, the problem of patient recruitment has continued to grow at an alarming rate. The failure of these new tactics to solve the problem has as much to do with their inherent limitations as it do with the lack of a comprehensive strategy for applying them.

Owing to her vast practical experience, the courser facilitator has the ability to package and present training material in a manner that gives attendees a holistic view of the topic as well as sufficient grasp of each individual component to enable logical and systematic implementation of the various action steps. This is one training opportunity that you definitely won’t want to miss.This training stands to differ from others as it is indeed based on real-life case studies and proven methodologies.

FOR FULL PROGRAM, PLEASE CONTACT MS. CHEW WAN LEEC@MARCUSEVANSKL.COM