American SciTech International Contract Research organization has successfully completed more 2000 early Phase I clinical trials in healthy, adult human volunteers, including vulnerable population in all major therapeutic categories. We have clinical trial experience in the following areas:

• First-in-man trials
• Escalation of Dose & Dose Range Studies
• Bioavailability studies
• Bioequivalence studies or Clinical equivalence studies for generic drug development
• Drug Interaction for generic drug development

Phase I Clinic set up:

• It is well equipped hospital with highly sophisticated ICU machinery
• The medical staff and physicians are fully qualified and well trained
• 20 hospital beds in a fully monitored clinic environment
• Ambulatory telemetry system
• 12-lead and rhythm ECG monitor
• Suction unit/aspirator
• Facilities for Arterial blood gases and artificial ventilators
• IV pump for medication delivery
• Crash Cart equipped with Defibrillator/Monitor, Oxygen Tank, Ambu Bag and Emergency Medications
• Fully FDA approved facility for Phase I Trials.

Team of Clinical & Medical Research Staff
We have clinical staffs who have received CRC certification from established industry organization such as SOCRA & ACRP (Association of Clinical Research Professional).

• We have experienced full-time and part-time clinical and medical staff available to work on clinical trial.
• Our medical staff comprises of Medical Director and Principal Investigator, Co-investigator and sub-investigators with many years of experience.
• The clinical study team comprises of highly qualified staff, including the medical staff (medical doctors), clinical research associates (CRA), clinical research coordinators (CRC), clinical research coordinator assistants (CRCA), medical assistants/nurses, and technicians.
• Ongoing training to staffs ensures the quality and outstanding performance on procedures and clinical studies during the clinical trial.

Subject Safety is our top priority:

• All study protocols are reviewed by HIGHLY EXPERIENCED STAFF to ensure subject safety and strict adherence to FDA regulatory standards & ICH – Guidelines.
• All studies are designed and conducted in accordance to strict guidelines regulated under the Food & Drug Administration (FDA) in U.S., the EMEA in Europe and APEC/ASEAN Chapter in India and other regions in ASIA.
• An Independent Review Board (IRB) reviews the study protocol and consent form and all the relevant material regarding clinical trial.
• We have a department dedicated to observe the adverse events. All AEs are documented and addressed during clinical trials.
• Safety management board and IND safety report management.
• Post study requirements include follow up of adverse events or any problem based on pre-study screening, follow-up visits and post-study physical examinations and clinical laboratory testing.