Clinical Research Services

Transcription

1 Jeevan Scientific Technology Limited a symbol of quality and diverse solutions Clinical Research Services

2 JEEVAN SCIENTIFIC TECHNOLOGY LIMITED Jeevan Scientific is an Independent Contract Research Organization, established in the year 1999, located in Hyderabad, India. In 2015, Jeevan incorporated its US arm. Jeevan has been built with state of the art facilities and expert resources to provide broad range of clinical research services for healthcare/pharmaceutical industries across the globe. Jeevan s service portfolio hosts a spectrum of services that enables us to provide an integrated solution for the management of clinical development right from its inception to completion and post-marketing. Jeevan is a perfect blend of technology, innovation and expertise, which enables us to provide reliable, cost-effective and technology driven services and solutions to clients. MISSION, VISION & VALUES To realize our Vision of being a clinical research organization (CRO) with global distinction, we ensure that our services adhere to the highest standards, which are at par with global quality standards, and set new benchmarks. Jeevan s quality policy is to achieve sustained and profitable growth by providing services, which consistently satisfy or exceed the needs and expectations of clients. Jeevan has continued to grow and evolve by attracting superior talent, developing valuable resources and investing in state-of-the-art facilities to deliver clients the best. Our commitment to quality, and customer-focused approach bundled with outstanding expertise distinguishes us from others.

3 SERVICE PORTFOLIO Clinical Operations CDM Ÿ BA/BE (Healthy/Patient) Ÿ Data management Ÿ Phase II to IV Ÿ Biostatistics and statistical Ÿ Trial Management programming services Ÿ Trial Supply Management Bioanalytical Pharmacovigilance Ÿ Subject sample analysis Ÿ Case processing Ÿ MD & MV Ÿ Aggregate reports Ÿ Pre-clinical samples Ÿ Signal detection and Risk management plans Regulatory Affairs Project Management Ÿ Dossier Management Ÿ Clinical site management Ÿ Strategy and Intelligence Ÿ Site identification and Vendor Ÿ Labeling and Publishing Ÿ Business & Outsourcing management Ÿ Monitoring reports review and submission Medical Writing Quality Assurance Ÿ Commercial Writing Ÿ Investigator, CRO site and Ÿ Scientific Writing qualification audits Ÿ Preparing investigator sites for inspections Ÿ Site monitoring services Ÿ For cause audits Ÿ Medical Writing and Technical Writing

4 CLINICAL OPERATIONS Services Ø Healthy subject and Patient based BE studies Ø Mixed gender studies Ø Post menopausal studies Ø PK/PD end point studies Ø Food and Drug interaction studies Ø Single and double blind studies Ø Studies on controlled drug substances Ø Single and Multiple dose studies (fast and fed) Ø Dose escalation studies Ø Execution of studies on various range of formulations like Orals (solid oral and liquid oral), injectable and inhalations Infrastructure Ø Dedicated Clinical facility with floor space of 20,000sq.ft Ø 4 independent access controlled clinic units with total of 132 beds Ø 2 ICU units each consist of 4 beds with all emergency equipment's Ø Biometric based software for volunteer registration Ø In-house Clinical diagnostic laboratory Ø Access controlled pharmacy with special provision to store controlled substances Ø Qualified medical staff (DM, MDs, general physicians and Paramedical team) Ø Temperature monitoring devices across the facility Patient based studies Ø Rich pool of clinical investigators across the country Ø Experience in wide range of therapeutic areas Ø Trial and Site management/monitoring by qualified and experienced CRAs Ø Dedicated Project Management for tracking of project and timely monitoring of data to help sponsor remain consistently aware of project status

5 BIOANALYTICAL RESEARCH Services Ø Method Development, method validation (MD and MV) and analysis of samples for clinical trials Pharmacokinetic studies BA/BE studies Drug interaction studies Early phase studies Ø Estimation of drugs and metabolites in biological matrix (using extraction techniques: SPE, LLE) of sample from pre-clinical and clinical studies Ø MD/MV of highly sensitive analysis Infrastructure Ø Dedicated Bio-analytical facility with floor space of 5000 Sq.Ft Ø Having provision to accommodate up to 12 LC-MS/MS Ø High end equipments (LC-MS/MS) with validated software Ø Provisions for handling of both normal and light sensitive molecules Ø New method development and validation is continuous process Ø Access controlled sample storage area with 24X7 sample receipt and monitoring Ø Method development and validation by Qualified and experienced team Ø Online temperature monitoring through Eurotherm

6 DATA MANAGEMENT, PHARMACOKINETIC & STATISTICAL ANALYSIS) Services Ø Customized Data Management services Assistance in study design CRF/e-CRF design Tables, Listings and graphs Preparation of Randomization schedules Development of Statistical analysis plan (SAP) Ø PK analysis and data simulation by using WinNonlin Ø Statical analysis by using validated tools like SAS Ø Development of report in e-ctd format Ø EDC (Electronic Data Capture) QUALITY ASSURANCE AT JEEVAN Ø Independent Quality Assurance Department & robust Quality Management System. Ø All projects performed at Jeevan are audited by our quality assurance department for compliance to USFDA, EMEA and other applicable regulations by following ICH-GCP guidelines and compliance. Ø Experience in handling several regulatory audits like UKMHRA, USFDA, Health Canada, WHO, ANVISA and MOH-Turkey PROJECT MANAGEMENT Ø All projects are handled by technically qualified and experienced project management team Ø Our Project managers have robust knowledge on global project management skills and experience in handling global projects Ø Representing the client in inside the organization by providing best support. Ø Our experienced PM will predict the possible risks of the project and ready with the mitigation strategies beforehand.

7 KEY DIFFRENTIATION Independent CRO Move smarter to patient studies Site relationships and multi-center study management expertise, coupled with therapeutic knowledge, help you successfully deliver early patient studies Public limited company Enhance your capabilities without adding fixed costs Experienced staff, global state-of-the-art facilities and clinical site relationships facilitate studies across a range of therapeutic areas, geography, size and complexity Experienced global project managers Pro-actively prepare solutions and take ownership of project and its deliverables Enhanced site performance Jeevan actively manages each site, ensuring that all protocols are followed and all goals are reached. Variablize costs and share risk Innovative partnering and alliance models reduce infrastructure costs and enhance strategic capacity planning. Effective study management Our Experienced project managers ensure consistent global procedures, rigorous oversight and easy access to integrated data.

8 Advantages with Jeevan Fully integrated scientific expertise team Leadership team at Jeevan has 125 years of Cumulative experience Hands on experience handling various projects in diverse therapeutic areas Team has experience in Execution of more than 1500 clinical research projects Offering varied range of clinical research services across Phase I to IV Global Operations Plot No. 1&2, Sai Krupa Enclave Near Lanco Hills, Golconda (PO) Hyderabad , INDIA US Of ce N Central Expy, Suite 8031 Dallas TX bd@jeevanscientific.com