Care Worldwide Inc Company Information

1. WHAT IS CARE ? Dr. Jayraj Desai MB BS; MS (Ortho.); DCRP Clinical Project Director Care Worldwide Inc New York USA

2. Who Are We? We are a Site Management Organization with our Corporate Head Quarter in New York, USA and we have sites in various countries around the world. At present we have a office staff of 24 in US and 75 in India and we are actively recruiting Clinical Research Professionals due to fast expansion and growth of the company as well as due to incoming Clinical Trials.

3. CARE SMO We have pre-screened, highly experienced, suitably qualified, and enthusiastic Principal Investigators for clinical trials in virtually any specialty in various locations worldwide ranging from an independent practitioner to a large network of physicians in hospitals and academic medical centers. All our Investigators meet the specific selection criteria outlined by the Sponsor or CRO.

4. All sites have experienced, licensed, full time and dedicated clinical research professionals comprising of both clinical and non clinical team to ensure the prioritized and accurate submission of regulatory documents, appropriate site orientation /initiation, patient recruitment as well as the collection of clean and accurate data.

5. Our sites are equipped with latest technology, in house lab facility to a central lab access for timely management of large number of patient lab. We have internal management and quality assurance system in place to ensure prompt and accurate completion of task and proactive handling of problems that may jeopardize the success of the trial.

6. Clinical Team Principle Investigator Sub-investigator Senior RN (Registered Nurse) Junior RN Research Assistant Lab Technologist or a Phlebotomist

7. Non Clinical Team Clinical Project Manager (CPM) Clinical Trial Monitor (CTM) Clinical Data Manager (CDM) Clinical Research Associate CRA) Quality Assurance (QA) Clinical Research Coordinator (CRC)

8. We ensure timely and accurate regulatory board submission and data collection. We provide access to a large patient study population with an international approach. We assess the sites for study patient population even before presenting an investigator thereby increasing the likelihood of enrollment goals. We make use of both carefully orchestrated advertising as well as site's own patient population or internal referral base to enroll patients.

9. Our Purpose To support the innovation and development of new drugs and devices through clinical trials in partnership with pioneering pharmaceutical, biotechnology, and medical device industries.

10. Our Goal To provide quality service, responsiveness, and results to our customers striving to be the finest resource and meeting their specific and unique needs.

11. What Is A Clinical Trial? A clinical trial is a scientific study of the effects, risks and benefits of a medical product, whether it is a new drug substance and / or currently marketed drugs .

12. Clinical Research Work Typical work activities can include: Locating, selecting, screening and briefing suitable doctors / consultants / investigators to conduct the trial; developing, writing and presenting the clinical trial protocols.

13. Setting up the Clinical Trial Sites and ensuring each site has the trial materials, & checking that the investigator knows exactly what has to be done.

14. Initiating, monitoring and close out of the clinical trials which will involve visiting the trial sites on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise.

15. Validating and collecting the completed CRFs from hospitals and consultant’s practices. Closing down the trial site upon completion of the trial. Discussing results with the statistician. A medical statistician usually carries out writing technical reports on the trial.

16. What Is CRA? Clinical Research Associate is a profession which administers and monitors the progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. Sponsor can be an individual or a pharmaceutical company. A CRA might also be called a Clinical Research (or Trials) Monitor, Executive, Scientist or Coordinator, depending upon the company.

17. Why the need for CRA training We strive for highest quality deliverables for our clients so our employees must be well trained and prepared for the challenges in the Clinical Research field. Sponsor requirements: The sponsor wants that all the persons involved in the trial must be well qualified and well trained. Increasing emphasis by the FDA (Food and Drug Administration, USA) for involving only trained and experienced persons into Clinical Trials.

18. Importance of this Course This course will provide the preparation you need to enter the pharmaceutical research area as a Clinical Research Associate (CRA) / Clinical Research Coordinator (CRC). CRAs / CRCs assume overall responsibility for assisting the investigator in conducting clinical studies of experimental drugs and devices .

19. Scopes Upon program completion, participants will be able to: describe the drug development process. describe the phases of a clinical trial list the responsibilities of sponsors, investigators, and institutional review boards. describe primary roles and responsibilities of the CRA & CRC.

20. Scopes (Continued) list the required contents of an informed consent form. identify documents that are part of an investigator study file. state how to grade and report an adverse event. understand the ethical principles guiding for the protection of human subjects. appreciate the types of Sponsor-Investigator site visits.

21. Careers Principal Investigator: MD/MS Licensed in its country of origin with 3-5 yrs. experience in the postgraduate therapeutic area with or without experience in clinical trials Sub-investigator: Fresh MD/MS/MBBS graduates with no experience

22. Careers (Contd.) Project Manager: PhD/ MBBS / Nurse Practioner with 5 yrs experience in clinical trials Clinical Data Manager: Computer Programming experience 2 yrs . or more Quality Assurance: Bachelors, Masters in Science

23. Careers (Contd.) Clinical Research Associate: MBBS, PhD, Pharmacist, Biotechnology Experience 2 yrs. or more as a Clinical Research Monitor Clinical Coordinator: Nurses BSN/Gen Nursing with 2 yrs. experience in nursing field Lab Technician: Lab Tech with Phlebotomy and Lab procedures experience to handle testing independently for 10 clinical sites at one time

24. Care Worldwide Inc Corporate Headquarter 38 West 32 Street Suite 405 Manhattan New York 10001 NY USA Phone: (001) 212-564-6412 Email: hr@careworldservices.com India (New Delhi) Main Office: 4th Floor Rectangle No. 1, Behind Marriot Hotel Saket, Commercial Complex D4, Saket, New Delhi. 110 017. India Branch Office: 15th Floor, Eros Corporate Tower, Nehru Place, New Delhi. 110 019. India Phone: 9311820116, 9350452427

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