A clinical research organization

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1 A clinical research organization

2 About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced GCP and GLP trained staff with ethical practices. Tie up with various hospitals in many major cities of India. Large volunteer database. Team of trained and experienced investigators working at various sites. Strong regulatory support.

3 About Us Well experienced Pharmacovigilance team for recording and reporting of AE. Asset ---- Independent Quality Assurance team which ensures that all work done are in accordance with GCP and GLP. Clinical services at Quantum envelope every aspect of clinical research, from individual Phase I studies to complete Phase IV programs as well as coordinating international multi-center trials. We work across many therapeutic areas and have experience with an ample range of product types, including vaccines, neutraceuticals, allopathic or ayurvedic or unani medicines, biologicals, orphan drugs and medical devices.

4 Our Pune Facility at IT BT Park, INDIA

5 Phase 1 Phase 1 Facility, Pune

6 Services Early Phase Phase I capabilities for bioequivalence studies and special population groups Proof-of-concept testing Scientific advice Full service capability through organizational partnerships

7 Phase I Services Protocol development, submission and approval from IEC. 42 bedded well equipped clinical trial unit along with ICU setup upgradable to 200 bedded. Bioavailability and bioequivalence studies Tolerability and Pharmacokinetic of escalating single dose. Facility at Pune, INDIA

8 Phase I Services Pharmacodynamic of single doses. Pharmacodynamic of repeated doses. Drug - Drug interaction studies Drug - Food interaction studies. Safety and Tolerability studies. Volunteer Accommodation Facility at Pune, INDIA

9 Services Phase I Scientific monitoring of all clinical research related events by an experienced team of Physicians, Nurses, Investigators, Clinical Pharmacologist, Pharmaceutical Scientist and Analyst. Covers large geographical area providing huge bio-diversity, economic diversity and gene diversity. In house catering unit to meet specific dietary requirements of volunteers. Cafeteria facility for Volunteers, Pune, INDIA

10 Services Phase I Well equipped medical screening and emergency facility including X ray machine, Defibrillator, USG and Cardiac monitors. Experienced medical writing team. Large volunteer data base. Cafeteria facility, Pune, INDIA

11 Services Phase II III Study design to site identification to patient recruitment Clinical monitoring Data management to statistical analysis to clinical reports to submissions

12 Services Phase IV /Post Marketing Surveillance Efficacy and safety claims, advertising, product labeling and other regulatory requirements are efficiently handled by trained professional. Well experienced Pharmacovigilance team for recording and reporting of AE. Risk management services. Drug Safety data base management. Serious adverse drug event processing. Complete review of data and submission to the regulatory agencies.

13 Services Late Phase Registries (Product / Disease) Health economics and outcomes research Observational studies

14 Services Pharmacovigilance Services Risk Management Drug Safety Database Management Serious Adverse Event Processing Data entry (and missing information assessment and follow up), Data review (QC process) Medical review/medical monitoring of SAE SAE narrative production. Literature Search Follow up of reported SAEs to resolution or stabilization

15 Services Regulatory Services Regulatory approvals of Phase I, II, III and IV trials Regulatory approvals for special trials Regulatory approvals for BA/BE studies Assistance in approvals of import license Regulatory Dossier preparation Product registration for marketing approval Guidance and assistance for regulatory submission Representation on behalf of sponsor DCGI submission Liaison work

16 Medical Writing Services Services Protocols CSR (Clinical Study Reports) IB (Investigator Brochures) ICF (Informed Consent Forms) Case Record Forms and Subject Diaries PSR (Periodic Safety Reports) Site Feasibility Reports Subject Narratives Regulatory Dossiers for registration of drugs and medical devices Product Monographs Pre clinical Pharmacology Reports Pre clinical Toxicology / Safety Study Reports

17 Medical Writing Services Services Translated Clinical Trial Materials Conference Documents SOPs & WP Documents Abstracts Synopses Manuscripts Scientific Papers for Publication Posters Slide Presentations Lectures / Training Material Meeting Reports

18 Services Quality Assurance Services The following services are provided by the Quality Assurance team of Quantum: -GCP/GLP Audits (In-process, retrospective & system audits) -Investigator Site Audits -Sponsor Audits -Systems Audits -Laboratory Audits -Clinical Trial Supply Audits

19 Services Quality Assurance Services -ln house Files facility -AE Reporting System Audits -Computer Systems Validation Audits -Database and Data Management audits -SOP writing and reviewing -Final Report audits -Archival audits WHO trained GLP trainers are auditors who have decade of experience in auditing and participating in audits by national / international / regulatory / competent authorities.

20 Services Clinical Data Management (CDM) Case Report Form and ecrf design Data entry - Double Pass & coding Data Analysis Oracle Clinical EDC Implementation & Project Management

21 Services CDM & Biostatistics Services Developing protocols / sample size Randomization SAP development Planning and implementing randomization Statistical consultation to clinical research & market support professionals Program and validate statistical Tables, Listings, Graphics ISS/ISE database preparation Data mining Interim and final analysis Support for regulatory affairs Statistical reporting

22 Clinical Trial Management Project management Strategy/Planning, Protocol writing, CRF design, Site planning, Regulatory, IEC/IRB, drug import, CRA training (product and study specific), CTMS) Site management Investigator recruitment Clinical monitoring Patient recruitment & retention

23 Therapeutic Areas Quantum offers extensive experience and capabilities in the following therapeutic areas: Oncology Diabetes Cardiovascular Gynecology Orthopedics Endocrinology Urology ENT GIT Pediatrics Ophthalmology Immunological Disorders Sports medicine We cover Allopathic, Ayurveda, Homeopathy, and Naturopathy.

24 Services at a glance Bio availability Studies Clinical Trial Monitoring Clinical Trials, Phase I Clinical Trials, Phase II Biostatistics Clinical Trial Data Management Quality Assurance / Quality Control Documentation Support Services Clinical Trials, Phase III Clinical Trials, Phase IV Medical Writing Services EDC Management Regulatory Affairs Services Clinical Trial supply management

25 Contact Manager Business Development Mobile: Website:

26 Thank you Please visit us a

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