1. Successful strategies in managing clinical trials:

• ASI is the leader in phase 1 & Phase 2 clinical trials and excellent in phase3&4.
• We have well planned goal oriented safe strategies for phase1&phase2 a clinical trial.

2. All phase 1 clinical trials are performed in the United states of American in the big well establish hospitals and by experience physicians.(Facility for phase 1 clinical trial given below)

• Phase 2, 3 & 4 Trials are performed in the U.S.A and also in other countries as per requirement.
ASI has made impressive and focused strategies in clinical Research. This will help pharmaceutical and biotechnological companies to maximize the return on their investment. We effectively handle health care and post marketing safety issues during and after the clinical trials. We have dedicated scientists, researches, physicians, nurse practitioners, research nurses, medical writers and statisticians on our team for writing and designing focused and goal oriented protocols. These professionals will explore the ways to motivate investigators, and drive high-performance site activity, that will provide a reference guide to the range of study designs possible in all the phases of study.

3. Clinical trial is an expensive and time consuming process:
Bring a new drug or medical devices to market can take 10-12 years and cost as much as $1 billion. Research, product development, and clinical trials involve not only the sponsor’s staff, but regulators physicians, academic researches, and patients. Throughout the process, information and sponsors, as well as to the worlds regulatory bodies. Experts in health economics and other related fields, analyze the market into which the product will be introduced. Specialist in preclinical evaluation, biologics production, clinical trial design and implementation, all play significant roles in taking a new drug or medical device from laboratory to market, safety, efficiently and cost effectively.

4. Outsourcing to Asian & European countries is even more accurate and economical:

We will straight away cut down the cost of entire clinical trial by 20%-30% without compromising the quality of the clinical study. We offer outstanding services for less money. We have well experienced physicians and fully equipped hospitals in India for good clinical health care for in-patient subjects participating in phase 1 studies and also all other clinical trials, from phase2-4

• The pharmaceuticals and biotech companies will take a advantage of the large population of patients in India
• Easier enrollment of eligible subject will permit vast range of clinical studies with no competition over the study subjects.
• The rapid enrollment of subjects will make the drug development process faster and more efficient.
• Our whole system is geared up towards the establishment of devoted clinical research center, experienced well trained investigators having full knowledge of ICH-GCP
• Dedicated clinical research associates standing by for monitoring the entire studies closely and accurately.
• Experience central labs, imaging technologies, data management systems, satellite communication and global shipping carriers make the work easier and more efficiently.

Furthermore, we speak your language which will make the communication more effective and smoother. “we speak English” American SciTech International eCROs; North American branch and all other branches are fully prepared to conduct FDA or ICH regulated clinical trials. ASI eCRO act as partners, helping clients address everything from subject recruiting to data- collection and analysis, from clinical trial planning to regulatory filing.

We Support you from beginning to end; IND to NDA & post submission activities, and also at times when an extra help is needed. CROs offer pharmaceutical, biotechnology, and medical device companies the resources and expertise to conduct clinical trials in a manner that is streamlined, professional, and cost effective. We are committed to accomplish your goal to succeed in bringing new products to the market. ASI is the most dependable name in designing clinical trials for application to the development and approval process for new drugs, and maintaining the reliability, and accuracy of data on which your success depends. We are thankful to our reputation for excellence.

Good Qualities of right CRO The rights CROs are recognized by their professional approach to clients, regulators, even competitors, and its employees comply with regulatory Good Clinical Practice (GCP) and HIPAA regulations. Their commitment to patient safety and research quality should be the best. CRO should provide regulatory expertise appropriate to a products unique clinical approach and market targets. Trials should be paired with stringent quality assurance procedures and detailed product management, to make sure deadlines are met and budgets followed. This is the ultimate source of increased revenue and cost effectiveness.

5. Hipaa Compliant Facility:

Our American SciTech international organization is compliant with the FDA regulation and HIPAA. We also follow the ICH guidelines for the drug development and medical devices at the International Sites. Our workforce is fully compliant with GCP, GMP, GLP and HIPAA

6. We specialized in the following studies: (Phase 1 to Phase 4)

• Clinical trials related to Oncology
• Highly effective large clinical trials related to cardiology, both drug & Device
• Use of Human Monoclonal antibody for various cancers treatment and other rare diseases
• Ophthalmic & neuropsychiatry is the field of high yield
• Endocrinology clinical trials tailored to your requirements
• Clinical trials conducted in all groups of infectious diseases //Immune Response Diseases
• Respiratory disease and allergic diseases
• We also specialize in clinical research related to pain management, rheumatology and other Auto-immune Diseases
• Studies of medical Device Implantation
• Pahse-1 to 4 clinical trials are conducted in the United States and at all three international sites.
• Studies for Bioequivalence/Bioavailability in Generic Drug development.

Details of Phase 1 clinical trial Facility American SciTech International Contract Research organization has successfully completed more 2000 early phase 1 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 1 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 hospitals 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
• 4 pump for medication delivery
• Crash cart equipped with defibrill/monitor, oxygen tank, ambu bag and emergency medications
• Fully FDA approved facility for phase 1 Trials.
• NOT limited to the above list, but it is more than that.

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 Professionals).

• 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 AE 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.

REGULATORY ISSUES IN U.S. & OVERSEAS US-Branch follows FDA Regulations Strictly:

• Focused on the details, objectives and outcome
• Full compliance to the GCP and strictly following SOPs
• Demonstrated service and commitment to quality, accuracy and time
• Locally available well reputed IRBs as well as use of centralized IRB reasonably.
• Innovative leadership
• Selection of well experienced, dynamic and knowledgeable principal investigator.
• Well trained study coordinators to the sites selected by ASI-CRO
• We have great experience and knowledge of site selection for maximum and accelerated recruitment of subjects.
• Well organized investigators meeting.
• Commitment to employee growth and retention.
• Comprehensive training & development
• Great communication and ease access to the clinical study staff 24/7
• We have proven to be effective liaisons between our client and the food and drug administration.

CLINICAL TRIAL OVERSEAS: ICH-GCP Guidelines related services in other countries…….

• Strategic planning & communication; we speak your English language.
• Global scale, universal standard
• In- depth, global experience
• Regulation guidance and compliance with international requirements
• Interface with regulatory authorities in India for fast approval of study protocol
• Locally available US trained energetic clinical research associates for accurate monitoring services.
• On schedule submission of study results electronically
• Central labs located in India with experience in clinical trials.
• Protocols design in coordination with Indian Physicians and Statistician.

Therapeutic areas and clinical trial phases 1-4 performed in the United States:

American SciTech Intl. is the safest place in the United States to Conduct Phase 1 clinical trials. We have well equipped well established hospitals and investigators physicians dedicated to safety of the study subjects and accuracy of the result during clinical trials. We conduct all phases of clinical trials; Phase 1-4 at the national and international levels.

Clinical Trials with Monoclonal Antibody:

American SciTech International is one of the best centers committed to conduct clinical trials with Human Monoclonal Antibody designed for the treatment of various rare diseases, immune response systems, infectious disease, and malignancies. We work with pure human monoclonal antibodies’ and also monoclonal antibodies attached to radioisotope element.

Expertise in various therapeutic areas:

We have broad-based experience in conducting clinical trials in various therapeutic areas. Our outstanding record and experience in clinical trials in cardiology, Endocrinology, Infectious Diseases, Immune Response Diseases, Neurology, Oncology, and Psychiatry, respiratory and gastroenterology, has given us a unique place in the clinical trial field. WE also specialize in clinical research related to pain Management, Rheumatology and other Auto-immune Diseases

Various indwelling devices: We have also served many national and international biotech and pharmaceutical companies for indwelling devices. Experience in Oncology Clinical Trial Management oncology CRO services We offer complete expertise in planning, designing and managing oncology clinical trial from phase 1 through phase 3. American SciTech International has experience team to plan drug development strategy efficiently and carefully according to your needs and scientific requirements. Our experienced business analyst can assist on budgeting and managing financial aspects of clinical trial. We specialized in therapeutic oncology clinical trials: Our outstanding experience in oncology clinical trial management will help accomplish your goal. Contact us for details about the trials; following is the list but not limited to the listing given below.

• Phase 3 clinical trial on advanced stage of Multiple Myeloma with human monoclonal antibodies:

Industrial sponsors: U.S based biopharmaceutical industry. International multiple center///Total patients’ population worldwide planned until 2010 is 1200 patients. CTMS: Project management, clinical monitoring and maintaining case report forms, SAE reporting, IND safety reporting, clinical data management, biostatistics analysis support and working within the budget. Current Status: web based Electronic data capture system of clinical Trial: Ongoing until December 2010

• Phase 2 Clinical Trial Generalized malignant Ascites & Pleural effusions.

Industrial Sponsors: International Biopharmaceutical Company. Multiple-center international///208 Patients are participating in the study Management: Project management, clinical monitoring and maintaining case report forms, SAE reporting, IND safety reporting, clinical data management, biostatistics analysis support and working within the budget. Current Status: Web based Electronic data Capture systems of clinical Trial: Ongoing until December 2009

• Phase 2 Clinical trial for Ovarian malignancies.

Industrial Sponsor: International biotech company based in Europe//European Union & APEC//ASEAN Chapter Multiple international sites//132 Patients are participating in the study CTMS: Project management, clinical monitoring and maintaining case report forms, SAE reporting, IND safety reporting, clinical data management, biostatistics analysis support and working within the budget. Current Status: Web based Clinical Trial is ongoing until December 2009

• Phase 1 Clinical trial : chronic lymphocytic leukemia.

Industrial sponsor: Private U.S Pharmaceutical Company. Multi-center//26 patients are participating in the study.CTMS: project management, clinical monitoring and maintaining case report forms, SAE reporting, IND safety reporting, clinical data management, biostatistics analysis support and working within the budget. Current status: Clinical Trial is ongoing until mid-July 2008

• Phase 0 & 1 Clinical Trial for Common solid tumors with dose Escalation.

Industry sponsors: U.S. public pharmaceutical company Multiple sites///30 Patients are participating in the study CTMS: Project management, clinical data management, biostatistics analysis support and working within the budget. Current status: web based clinical trial is ongoing until fall 2008

• Phase 1 Non-Hodgkin’s lymphoma (first-in-human).

Industrial sponsors: Medical device and Biopharmaceutical Company Multi-center study/// 57 Patients are participating in the study Project management, clinical monitoring and maintaining case report forms, SAE reporting, IND safety reporting, clinical data management, biostatistics analysis support and working within the budget. Current status: Clinical Trial is ongoing until end of 2008

• Phase 1 Multiple myeloma advance stage Treatment with human monoclonal antibody with radio isotope attachment.
Industrial Sponsor: European Union based public biotechnology company Multiple centers/// 23 Patients are participating in the study. CTMS: Project management, clinical monitoring and maintaining case report forms, SAE reporting, IND safety reporting, clinical data management, biostatistics analysis support and working within the budget. Current Status: Completed end of Dec 2005 and study started on Phase 2 Nov 2007