Clinical Trials & Research

Sai Hospital & Research Centre is regularly conducting Clinical Trials in different diseases as Asthma, Allergic Rhinitis, Vaccines, Growth hormone, ADHD drugs, Autism trial, Antipyretic trial, Drugs on Otitis media, Drugs on Vitamin–D deficiency, Juvenile Diabetes, Malaria, Nutritional supplements.

Clinical Trials really help community by new research molecule helping to control the diseases. Poor patients with costly treatment condition get free treatment e.g. growth hormone deficiency, vaccines.

Sai Hospital & Research Centre is extremely well placed to conduct clinical trials for different diseases, at a local, national and international level, owing to well defined patient populations.

Sai Hospital & Research Centre:

  • Has a strong data base of patients of different diseases.
  • Has a regular referral from more than 1000 Family Physicians for different diseases.
  • Has different specialists like Neurologists, Cardiologists, Surgeons, Physicians, Diabetologists, Rheumotologists, etc. attached to it.

Our Charitable Foundation, Universal Health Foundation is instrumental in organizing free health check up camps in adjacent rural areas & urban slum areas. Eventually, it facilitates considerable number of patients for clinical trial looking forward towards the benefit of free treatment & these are needy patients.

Our Expertise:

  • Sincere and diligent professional team with an overall cross–functional experience of over 5 years across Clinical Research, Pharmacological Research, Neutraceutical Research and Quality Control.
  • Proficient in swiftly ramping up research projects with cross–functional skills & ensuring deliverables within stipulated time frame. Expertise in project planning, scheduling & resource planning to achieve specific research targets
  • Thorough academic exposure and dexterity across regulatory guidelines and submission procedures in regulated markets; adept at preparation of protocol, CRF and clinical reports.
  • Exceptional planning and execution skills coupled with a systematic approach and quick adaptability. Solid ability to translate technical information and provide training to staff and patients.

Our Responsibilities:

  • Conduction of Medical Study Examination (Monitoring Vitals, Physical Examination, Systemic Examination)
  • Review of ECG for volunteer during screening.
  • Review of the lab reports and recording details in relevant documents.
  • Assisting in Hospitalization of Study subject.
  • Recording of adverse events and management of it with the intimation of principle investigator and Filling of details of adverse event form.
  • Keep a close association with site for: Patient Recruitment, Patient Follow Up, protocol related activities
  • Help in preparation of Regulatory Binder Ensuring that conduct, recording and reporting of clinical trials is as per ICH–GCP guidelines, ethical considerations and SOP’s.
  • Review of Clinical Trial Protocol and preparation of protocol amendments.
  • Review of CRF and Patient Information Sheet and Consent Form
  • Design & Review of Media (Newspaper) Advertisement for clinical studies as per ethical considerations.
  • Review of Investigational Products and other clinical trial materials (CRF’s, patient information sheets and their translated versions, Pharmacokinetic kits, schedules for activities during the conduct of trial).
  • Maintaining and completion of essential documents for EC submissions.
  • Ensuring prompt recording and reporting SAE (Serious Adverse Events) to regulatory authorities.
  • Interaction with Central Laboratory, IEC, CRO, CRA for ensuring GCP compliance.
  • Updating the investigator processing and shipment of Pharmacokinetic and clinical
  • Laboratory Samples as per GLP.
  • Design & Review of Media (Newspaper) Advertisement for clinical studies as per ethical considerations.
  • Updating the investigator site logs.
  • Query resolution generated by monitors and auditors.

We have experience of various therapeutic areas like oncology, neurology, gastroenterology, psychiatry, infectious disease, vaccines, cardiology. We have worked on more than 15 projects ranging from Phase II – Phase IV studies, performing different activities right from start – up activities to archival of data.

Our focus has always been on maintaining the top quality of data, and to meet the set time lines. We have always focused on constant practical training of our site staff.

We strive to constantly work on improving the quality of data generated in clinical trials.

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