What Is Care?
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What Is Care?

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Care Worldwide Inc

Care Worldwide Inc
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What Is Care? What Is Care? Presentation Transcript

  • WHAT IS CARE ?
    Dr. Jayraj Desai
    MB BS; MS (Ortho.); DCRP
    Clinical Project Director
    Care Worldwide Inc New York USA
  • 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.
  • 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.
  • 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.
  • 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.
  • Clinical Team
    Principle Investigator
    Sub-investigator
    Senior RN (Registered Nurse)
    Junior RN
    Research Assistant
    Lab Technologist or a Phlebotomist
  • 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)
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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
  • 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
  • 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 
  • 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
  • Tajmahal would not have been this beautiful
    if Shahjahan would have asked for the quotations
    and
    would have gone for the lowest
  • Thank You