A ‘Gurukul’ for Clinical Research

Learn from Industry Experts

“How to become Professional in Clinical Research with

State-of-the-Art Infrastructure and Hands on Training”

We take this opportunity to introduce ourselves as a leading Clinical Research Organization in Mumbai, India. To meet the current “Global Requirements in Clinical Research”, NexusCRO has  launched  an  innovative  Educational  Training  Programs  in  Nexus-CRI(Nexus  Clinical Research Institute), a specially designed and developed opportunistic vision to enrich the stream of  Clinical  Research  Professionals  who  could  combat   the  dearth  of  quality  manpower  in  the Clinical Research Industry. Nexus-CRI serves you with a platform that trains all aspirants to be well prepared to meet the needs of this “Ever-evolving Industry” with Disseminating Knowledge and Skills in Core and frontier areas of Clinical Research.

Training Programs are customized according to the needs of the students, who work in facilities meeting International  standards  and  are  trained  by  a  dedicated  team  of  Industry  Experts  and domain Consultants who  are  well  experienced  in  the  field  of  Clinical  Research in real ‘Gurukul’ discipline.

Courses Offered at Nexus-CRI:

Ø Post-Graduate Diploma in Clinical Research Management- (PGDCRM)

Duration: ONE YEAR FULL TIME

Ø Advanced Post graduate Diploma in Clinical Research (PGDCR)

Duration: SIX MONTHS WEEK END

Ø Post graduate Diploma in clinical research (PGDCR)

Duration: SIX MONTHS DISTANCE LEARNING

Ø  Certificate Course in Clinical Research-(CCR)

M Duration: TWO MONTHS FULL TIME.

Eligibility:

Applicants  are  recommended  to  have  one  of  the  following  life  Science  degrees:  Bachelor's,  or  PhD,  MBBS/MD/B.D.S/M.D.S/B.A.M.S/B.U.M.S/B.H.M.S/B.Tech(Biotechnology/Pharmaceutical  Science) /      B. Pharmacy/BVSc/MVSc/B.Sc.(Nursing) B.Sc./M.Sc life science, M.Sc / M.A(Statistics) or any other stream in life sciences can apply .

Course Details:

Centers:   

                   DELHI Gurukul, MUMBAI Gurukul

Fees:

Rs. 1, 60,000 /- for Regular Programs (12 months)

Rs. 75,000 /- for Weekend Programs (6 months)      

Rs. 45,000 /- for Distance Learning Programs

‘Which Covers Tuition fee, Personality Development, Course Materials, assignments, Text Books Online Course Access, Resume Evaluation, Job Placement Assistance, and Certification’ Fee can be paid in three installment*

Placement:

Guranteed Placement would be providedto the  candidates .Campus Interviews, CV’S of successful candidates would be forwarded to CRO’s, Pharma Companies and Potential Employers.

Students scoring “A+” would be absorbed parent company, Nexus Clinical Research (NexusCRO) one of the largest CRO in the country.

HOW TO OCCUPY YOUR SEATON FIRST COME FIRST SERVE BASIS:

Send Rs. 550/- DD  / At Par Cheque in the favor of  "Nexus Clinical Research Pvt. Ltd( Institute)"  payable at Navi Mumbai, for Complete “Gurukulam Info”

Hurry up……book your seat for July 2009 Batch. There are limited seats available and the admission is on the basis personal interview and written test.

COURSE CURRICULUM:

Ø CRASH COURSE (2 MONTHS)

1.    The Food and Drug Administration Past and Present.

·        The Establishment of the Food and Drug Administration;

·        The History of the Legislation and Regulations, which Govern the Clinical Research Process;

·        The History of the Legislation and Regulations, which Protect the Rights, Safety, and Well-Being of Human Subjects.

2.    Overview of Medicinal Product Research and Development.

·        Drug Discovery and Pre-Clinical Research;

·        The Clinical Research and New Drug Application Approval Process;

·        The Biologics Research, Development, and Licensing Process;

·        Medical Device Research, Development, and Marketing.

3.    Good Clinical Practice (GCP)

·        Investigational New Drug Application 21 CFR 312: Sponsor’s Obligations;

·        Investigational New Drug Application 21 CFR 312: Investigator’s Obligations;

·        Institutional Review Boards 21 CFR 56;

·        Protection of Human Subjects 21 CFR 50;

·        Financial Disclosure 21 CFR 54.

4.     International Conference of Harmonization

·        The History of the International Conference of Harmonization;

·        The ICH Good Clinical Practice Consolidated Guideline (E6);

·        The ICH Clinical Safety Data Guideline (E2).

5.    Clinical Trial Development

·        Protocol Design and Development;

·        Case Report Form Design and Development;

·        Principals of Data Management and the Query Resolution Process;

·        The Study Types Providing Expanded Access to Investigational Products.

6.    Clinical Trial Management

                   Investigator Site Perspective: Coordinating a Clinical Trial at the Site

·        Essentials of Source Documentation;

·        Maintaining and Managing Essential Documents;

·        Recording and Reporting Non-Serious and Serious Adverse Events.

Sponsor’s Perspective: Managing a Clinical Trial

·        Selecting Investigators and Monitors;