Professional Diploma in Clinical Trial Management (PDCTM)

SICR is offering a training program in clinical research that is Professional Diploma in Clinical Trial Management for recent graduates in Pharmaceutical Science, Medical Science, Dental Science and Life Sciences who are interested in pursuing a career in clinical research. its a 6 months program covering the entire spectrum of drug development and clinical research from drug discovery, medical monitoring, regulation, operations, quality assurance, biostatistics, data management, project management to soft skill development. The program also includes approximately 24 hours of dynamic workshop training at our facility and study sites. which is given to 25 selected candidates.

Program Highlights

•PDCTM is a 6 months distance education program.
• Evaluation is on the basis of online examination.
• Faculty includes experts having more than 6 years of cumulative experience in the clinical research.
• Online practical work is the key feature of PDCTM

Clinical Research Profession: an unmet need India is today poised as one of the favorable destination for Clinical research field in terms of large research & development (R&D).

Clinical research is a highly specialized field that requires specialization in pharmaceutical science & training to carry out various job functions. The need and complexity of the specialization and training at the level of R&D, quality assurance (QA) as well as academics, increases as they move up the professional ladder thereby shifting the focus from ‘trouble shooting’ to ‘planning & forecasting’.

KPSCS is aimed at imparting clinical research training / education as per the company act 1956, Government of India in the visual appearance of PDCTM, with specialization in clinical trial methodology and management science skills required for the professional growth & competency development at the level of R&D and clinical research professionals.

Training Objective(s)

1. To provide an in-depth knowledge & opportunity for skills development in Clinical research.

2. To nurture the culture of 100% clinical research-Competency development

Target audience

Specialization in clinical research professionals employed in pharmaceutical companies, Hospitals, contract research organizations (CROs), research & academic institutions etc as job prospects.

Following positions are available to pursue a career in clinical research:

Clinical Research Scenario in India:

India became a member of WTO/GATT/TRIPS in 1995 and implemented the product patent regime in 2005. As part of WTO/GATT/TRIPS, Pharmaceutical Industry has the right to patent products as well as processes throughout the world including India. This has led to a significant growth in pharmaceutical industry and increased stakes of multi-national companies in Indian operations.

"The quality of global trials and academic clinical research is not uniform. There are also issues of inadequate permanent research staff and lack of adequate infrastructure for communication, drug / sample storage, archival. The situation is worse in non-metro cities that have tremendous potential for participation in global trials. In addition, the institutional policies are not yet geared up to support the investigator in managing clinical trials efficiently." It has noted.

Most medical / Pharmaceutical institutions lack a formal course in training for clinical research, and clinical research professional like investigators / monitors have relied on mentors to learn how to conduct clinical trials. There is a shortage of trained manpower. India has about 500 - 1000 clinical research professional in the country, as compared to United States that has 50,000 clinical research professional. With the projections made for the industry in 2010, India would need about six times its present number of investigators. Regulatory approvals in India can take three months or more, compared to 30 days in the US.

In light of these changes, Clinical Research has emerged as a leading knowledge based industry of the new millennium. Clinical research is carried out on healthy volunteers and patients with diseases to ensure that the drug, which is to be marketed, is safe & effective. It takes approximately 12 years and US $900 million to introduce a new drug to the market.

Being a signatory of GATT/TRIPS, India is being looked upon as a favorable destination for conducting global clinical trials. India offers unique advantages that include:

• Lower drug development cost

• Abundance of patients with genetic diversity

• Wide spectrum of disease

• Trained medical professionals

• Skilled manpower and IT enabled infrastructure at a lower cost

• Proficiency in English language

An estimate of total market of clinical trial conduction either directly or through contract research organization in India by 2010 is projected at US $ 1.5 billion by major Pharmaceutical companies. This in turn offers huge employment opportunities for the pharmacy/Medical /life sciences graduate and post-graduate students. However, clinical research is highly specialized and regulated profession therefore it requires specific skill sets to carry out various operations, as per global norms.

We at KPS Clinical Services Pvt. Ltd. are committed towards developing India as a hub for global clinical research by catering to the ever-growing training and compliance needs of the profession, through specialized training courses and workshops.

Program Director:

Mukesh Kumar M.Pharm (Clinical Pharmacy), CPSR (USA) Director-Clinical Operation & QA, KPS Clinical Services Pvt. Ltd., Having more than 6 years clinical research experience as Clinical Research Coordinator, Clinical Research Associate and Project Manager in various clinical trials in the oncology, dermatology, anesthesiology, endocrinology across various Indian hospitals.

• Editor-in chief, The Clinical Research Plus- an India’s first clinical research Magazine

• Awarded certificate of FDA MedWatch and patient safety from US FDA

• Executive Member of scrutiny council, Clinical Research Board, India

• Member of IPGA, India

• Director- Administration, R.V. Northland Institute, Greater Noida

About Training:

SICR is offering a training program in clinical research that is Professional Diploma in Clinical Trial Management for recent graduates in Pharmaceutical Science, Medical Science, Dental Science and Life Sciences who are interested in pursuing a career in clinical research. It’s a 6 months program covering the entire spectrum of drug development and clinical research.

Programs overview:

Clinical Trial Management consists of multi-disciplinary approach of skills enhancement including induction, self-reading and online examination. The total course duration is 6 months.

Course Curriculum

All the students enrolled for PDCTMTM are committed to uphold the highest standards of personnel & professional behavior. The PDCTMTM program consists of four modules in all. The components of four modules are as follows:

Eligibility

1. Graduate & Post graduate in Pharmaceutical Science(B.Pharm, M.Pharm)

2. Graduate & Post graduate in Medical Science (MBBS, BAMS, BHMS,BUMS,MD, MS)

3. Graduate & Post graduate in Dental Science (BDS,MDS)

4. Graduate & Post graduate in Nursing Science

5. Graduate & Post graduate in Physiotherapy( MPT, BPT)

6. Graduate & Post graduate in Life Science

7. Working Professionals with relevant qualifications

8. Third year students of Pharmaceutical, Medical, Dental science are also eligible.

Note: KPS Clinical Services Pvt. Ltd. Is authorized organization to provide Education certification / corporate training / workshop / seminar for capacity building in the field of clinical research along with Clinical Trial Execution as per the company act 1956 of Government of India.

Demand Draft:

Candidates are required to send their completed applications along with a Demand Draft of ‘requisite program fee’ drawn in favor of ‘KPS Clinical Services Pvt. Ltd.’ payable at Greater Noida. Candidates are advised to write their name and address at the back of demand draft.

Scope of Clinical Research:

A looming shortage of clinical research personnel estimated at 30,000 to 50,000." McKinsey has estimated, and Confederation of Indian Industries concurred, that India's clinical research sector, including pharmacovigilance would grow to at least Rs 4500 crores in 2010 from Rs 450 crores, a ten-fold increase.