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Smo hhc research

Date post: 27-May-2015
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www.hhcresearch .com [email protected]
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2. Healing Hands Clinical Research Services is a Site Management organization withbroad spectrum of activities including site management, clinical operations andsafety management supporting early-phase through late-phase clinical developmentprograms.We have extensive working knowledge of a wide range of products such asPharmaceutical/ biotechnology products, biologics and herbal products and allactivities are carried out in strict compliance with ICH GCP, schedule Y, ICMR and allapplicable guidelines.What We AreCont 3. Our comprehensive investigator database and expertise in various therapeuticareas like General Surgery, Medicine, Diabetology, Oncology, Cardiology,Nephrology, Immunology, Rheumatology, Infectious diseases, Gynecology,orthopedics and Gastroenterology..etc give us significant leverage in providingfaster patient recruitment, cost competitive trials, yet world-class clinical support. 4. Our Team:Highly experienced and receptive team5 to 10 years experience in the Pharmaceutical industryWell trained and potential staff (ICH-GCP, ICMR, Schedule-Y and FDAregulations)Having Comprehensive project management team, quality expert managementteam and potential site coordinatorsExperience with all phases of clinical trials (Phase II -IV) across multipletherapeutic areas, in both paper and EDC environments 5. Our StrengthsManage Global as well as domestic clinical trials with precision and perfection.Timely execution of sponsors/CRO requirementsPotential Investigators and sitesFaster Patient RecruitmentMaintaining quality of the dataResolving and responding to all the queries within timelinesStrict compliance with study timelines and protocolWork with a variety of sponsors compoundsEffective communicationImmaculate track record for delivery on time and with qualityCompliance 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 tothe market faster.As a site management organization, we endeavor towards high quality, work ethics, andexcellent performance so that the study is conducted properly and fruitfully. We have a good experience in the complete process - site evaluation, site initiation, sitemanagement and finally site closeout so we can ensure prompt response at every stage ofthe study. 7. We Involve in:A) Pre Study initiation Identification of Potential Sites Faster Feasibility completion Site set up, supplies and other infrastructure needs Regulatory and IEC communications Rapid negotiation of CTA with CRO/Sponsors and investigators Setting up Standard Operating Procedures (SOPs) for site 8. B) During the Study/Trials Provide dedicated, trained and experienced CRCs (Clinical researchcoordinators) Patient recruitment & retention Support Maintenance of essential documentsMaintenance of TMF (Trial Master Files) Source documentation as per ALCOA standards (Attributable, Legible,Contemporaneous, Original & Accurate) IP(Investigational Product) storage, maintenance and accountability Completion of CRFs within timelines Cont.. 9. Faster query resolution Reporting of AE, SAEs to the sponsor and Ethics committee withintimelinesTimely submission of CIOMS to the IRB/IEC Support Monitoring visits and Quality Assurance audit action items Patient visit Follow Up and compliance assistance Preparation of site for monitoring and audits/ inspections Project management and quality management by quality experts. 10. C) Pre Close out and Post Close out Preparation for site Close out visitArchiving of site results and documentsPreparation and maintenance of quality in case of management of clinicaltrials data and medications at hospital or institute level is one of the bestservice provided by us. 11. Therapeutic areas:Healing Hands Clinical Research services deals with all major Therapeutic areaswith Indias leading and potential Investigators.We expertise in following therapeutic areas:1.Medicines2.Hematology3.Endocrinology4.Infectious Disease5.Gastroenterology6.General Surgery 12. 7. Oncology8. Cardiology9. Neurology10. Nephrology11. Psychiatry12. Orthopedic13. ENT14. Obstetrics & Gynecology15. Pediatric16. Herbal Research17. Neutraceuticals 13. Our Specialties:We offer quality services for investigators, enabling them to organize, performand execute successful clinical trials.We are mostly affiliated with Multi-specialty Hospitals across India.As a Site Management Organization, we assist Clinical Investigators andHospitals who have excellent sites to qualify for new clinical trials. 14. Our Project management and quality experts team will assure the quality of the data.We work closely with Sponsor/ CROs as a team and provide end to end sitemanagement solutions.We perfectly understand that successful trial outcome is a necessity and timely resultswill help you to get an edge over your competitors. 15. Why choose HHCRS:Full range of clinical SMO servicesQuality driven workWe manage, plan, and execute clinical trials with precision and perfection We are a dedicated, meticulous group of professionals who consistentlyproduce quality work.Having High recruitment sites across India.Accelerating work strategies right from feasibility, site selection to siteclose out.Dedicated and potential coordinators working at the sites.Compliance with the protocol and applicable regulatory guidelines. 16. Healing Hands Clinical Research Services4th Floor, Millennium star Extension,Above KFC, Adjacent to Ruby Hall Entrance Gate,Dholepatil Road, [email protected]


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