www.hhcresearch .com info@hhcresearch.com

1. www.hhcresearch .com info@hhcresearch.com

2. What We Are Healing Hands Clinical Research Services is a clinical Research Service Provider which has broad spectrum of activities including clinical operations, feasibility, project management, medical monitoring, safety management and regulatory services supporting early-phase through late-phase clinical development programs. We have extensive working knowledge of a wide range of products such as Pharmaceutical/ biotechnology products, biologics and herbal products and all activities are carried out in strict compliance with ICH GCP, schedule Y, ICMR and all applicable guidelines. Cont…

3. Our comprehensive investigator database and expertise in various therapeutic areas like General Surgery, Medicine, Diabetology, Oncology, Cardiology, Nephrology, Immunology, Rheumatology, Infectious diseases, Gynecology, orthopedics and Gastroenterology..etc give us significant leverage in providing faster patient recruitment, cost competitive trials, yet world-class clinical support.

4. Our Team: • Highly experienced and receptive team • 5 to 10 years experience in the Pharmaceutical industry • Well trained and potential staff (ICH-GCP, ICMR, Schedule-Y and FDA • regulations) • Experience with all phases of clinical trials (Phase II -IV) across multiple • therapeutic areas, in both paper and EDC environments • Immaculate track record for delivery on time and with quality

5. Our Strengths • Manage Global as well as domestic clinical trials with precision and perfection. • Having Comprehensive project management team, quality expert management • team and potential site coordinators • Timely execution of sponsors/CRO requirements • Potential Investigators and sites • Faster Patient Recruitment • Maintaining quality of the data • Resolving and responding to all the queries within timelines • Strict compliance with study timelines and protocol • Work with a variety of sponsor’s compounds • Effective communication • Compliance with FDA, local regulatory and ICH-GCP guidelines.

6. Our Services: • We offer a broad range of specialized services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to the market faster.   • We offer: • Site Selection and Site Feasibility • Project Management • Monitoring • Safety management • Regulatory Services • Site Management Services • We have a good experience in the complete process - site evaluation, site initiation, site management and finally site closeout – so we can ensure prompt response at every stage of the study.

7. Feasibility and Site Selection At Healing Hands Clinical Research Services, the feasibility process is at the core of our project planning and proposal activity. The feasibility group at Healing Hands Clinical Research Services has worked on virtually every therapeutic area and has direct contacts with key investigators and trial sites. Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial. Our well experienced feasibility and site selection Manager will visit the sites and evaluate the site facilities for conduct of clinical trials.

8. Project Management • Project management teams has therapeutic expertise from all appropriate functional areas . • The project team ensures customers are provided a notably high quality of services with proactive management techniques and timeline control. • They demonstrate their proactive approach by giving close attention to client “pain points” and relieving their concerns by addressing them in detailed Risk Assessment and Mitigation Plan

9. Medical Monitoring Clinical Monitoring – the Trial’s Backbone Our CRAs bring strong monitoring and clinical experience to our customers with most of their experience in key therapeutic and specialty areas. In addition, each member is fully trained in FDA regulations, ICH guidelines, and GCP/SOP compliance. As a result, our regionally based monitors thoroughly understand the many complexities associated with trials in the therapeutic area in which they primarily practice, in the region within which they work and accordingly, provide quality and performance feedback, study training and technical support, data query resolution, source document review, and site management for all types of visits.

10. Safety Management Safety Management: Through a team of dedicated and experienced Safety Physicians, we provide- highly credible inputs for the design of comprehensive study specific safety management plans, to ensure AE’s & SAEs are reported and processed accurately as per the regulatory guidelines. The safety management services Include: •AE and SAE case receipt, coordination and processing•Medical review of AEs and SAEs•Verification of AE coding•Preparation of safety narratives•Perform expedited safety reporting•Reconciliation of SAEs•Reconciliation of safety database with CRFs

11. Regulatory Services • Healing Hands Clinical Research Services provides regulatory services to facilitate all stages (Phases I-IV) of drug development. • Our ability to assist sponsors obtain regulatory approvals is supported by a deep understanding of, and experience in dealing with the Indian drug control regulations. • We have the ability to provide services as a complete study management and/or as customized services. • Services:Preparation, compilation and submission of regulatory dossier to DCGI.

12. Therapeutic areas: Healing Hands Clinical Research services deals with all major Therapeutic areas with India’s leading and potential Investigators. We expertise in following therapeutic areas: • Medicines • Hematology • Endocrinology • Infectious Disease • Gastroenterology • General Surgery Oncology • 8. Cardiology • 9. Neurology • 10. Nephrology • 11. Psychiatry • 12. Orthopedic • 13. ENT • 14. Obstetrics & Gynecology • 15. Pediatric • 16. Herbal Research • 17. Neutraceuticals

13. Our SOPs Established procedure followed by us in carrying out a given operation 1.Protocol writing & development 2.Vendor Selection & Agreement 3.Regulatory affairs 4.Study Start-up 5.Project Management (up to site close-out) 6.Subject Management 7.Data Management 8.Quality Assurance & Quality Control

14. Our Specialties: • We offer quality services for investigators, enabling them to organize, perform and execute successful clinical trials. • We are mostly affiliated with Multi-specialty Hospitals across India. • As a Site Management Organization, we assist Clinical Investigators and • Hospitals who have excellent sites to qualify for new clinical trials.

15. Our Project management and quality expert’s team will assure the quality of the data. • We work closely with Sponsor/ CRO’s as a team and provide end to end site • management solutions.

16. Why choose HHCRS: • Full range of clinical SMO services • Quality driven work • We manage, plan, and execute clinical trials with precision and perfection • We are a dedicated, meticulous group of professionals who consistently produce quality work. • Having High recruitment sites across India. • Accelerating work strategies right from feasibility, site selection to site close out. • Dedicated and potential coordinators working at the sites. • Compliance with the protocol and applicable regulatory guidelines.

17. Healing Hands Clinical Research Services 4th Floor, Millennium Star Extension, Above KFC, Adjacent to Ruby Hall Entrance Gate, DholePatil Road, Pune-01. www.hhcresearch.com info@hhcresearch.com