In today’s global Life science Environment, India represents the largest potential drug market in the world and the great threat to the people in a country like India where adherence to medical ethics is a rarity. Clinical Research has acquired new dimensions, which is exciting and same time overwhelming. It raises some delicate and difficult issues of ethics, which need to be addressed with high priority. Therefore any ethical guidelines on research, which followed by ethics committee, needs a sensitive balance of the risks and benefits said Mr. H.S.Dakshina Murthy, Member, Ethics committee, Apollo Hospital, Hyderabad here on Saturday the 5th April 2008.
He was speaking as chief guest for workshop on Good Clinical Practice (GCP) and Ethics in Clinical Trials organised by MakroCare, a Fastest growing global CRO, taking a lead in providing series of informational Workshops and Seminars to build an ecosystem of professionals for clinical research industry, with an objective to provide overview of clinical research process with review on GCP compliance and importance of Ethical procedures in clinical trials.
Later, in his presentation he explained about the ways to ensure that the trials are conducted ethically and within the framework of regulation and guidelines ensuring uniform quality of Clinical Research throughout the country and to generate data for registration of new drugs before use in the Indian population.
The second presentation was on “monitoring clinical trial for GCP compliance” by speaker Mr. Pawan Bhusari, Manager, MakroCare, Hyderabad. The speaker explained about the importance of ICH Good Clinical Practices (GCP) and how monitoring is important to ensure the GCP compliance in clinical trial. “Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects. Compliance with this standard provides public assurance of the rights; safety and well being of trial subjects and to ensure credibility of the clinical data,” He said.
More than 30 Doctors from various hospitals conducting trials, about 25 Clinical Research Associates, Clinical Research Co-ordinators, Project Managers, Statisticians, about 15 Pharma Students were present as delegates and made the workshop a grand successful event.
Presiding over the function Mr. Subba Rao, CMD of Makro said “Makro is serving the Life Science industry since more than a decade. This workshop is organized to build rapport of Clinical Research Professional as well as industry”.
Earlier, Ms. Indira Velala presented the welcome address and about the Makrocare Services. In her presentation she explained about the different services of Makrocare like International Clinical Trial Management, Clinical Monitoring, Clinical Data Management, SAS, Biostatistics, Medical Writing, Quality Assurance etc. about the Achievements of Makrocare, Certifications and infrastructure. Ms. Lalitha Ivaturi welcomed the guests, dignitaries, delegates, participants of the workshop and steered the programme. Dr.Renu Gaur proposed vote of thanks. Mr. Satish, Mr. Rajashekharam Chidara and other staff members of Makro witnessed the learning occasion.
MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company offers site selection, patient recruitment, project and data management, clinical monitoring, quality assurance, medical writing, PMS/PharmacoVigilance, biometrics, and regulatory assistance. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania) and India (Hyderabad).