Jeevan Scientific Technology Limited “a symbol of quality and diverse solutions” Hyderabad- India

Expanded to a “full service” Clinical Research Organization Jeevan: Timeline Expanded to a “full service” Clinical Research Organization Started medical writing division 2014 Established as global management consulting, technology services and outsourcing company 2011 1999

Our Mission, Vision and Values At Jeevan, our mission is to deliver value added, reliable and cost-effective services to our customers, through our core values. Vision To be an integrated CRO with global distinction, aiming for long-term partnership with our customers based on shared beliefs and goals for synergetic growth. Values Quality, Customer service, Integrity, Teamwork, Commitment, Accountability, Innovation, Personal Growth, Initiative, On-time delivery.

Jeevan Quality Policy To ensure that our services adhere to the highest standards which are at par with global quality standards and even setting new benchmarks. To achieve sustained and profitable growth by providing services, which consistently satisfy the needs and expectations of customers. Quality is not just another goal, but is a basic strategy for survival and growth, hence we promote a quality-in-all-we-do philosophy with a total company effort and commitment to continuous improvement. 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 even setting new benchmarks. Jeevan quality policy is to achieve sustained and profitable growth by providing services, which consistently satisfy the needs and expectations of customers. We recognize that quality is not just another goal, but is a basic strategy for survival and growth, hence we promote a quality-in-all-we-do philosophy with a total company effort and commitment to continuous improvement.

Our Commitment To maintain global quality standards To meet with clients’ needs through Professional teamwork Efficient communication Timely delivery To add value to clients’ products To maintain global quality standards

Jeevan Services Clinical Research Services Bioanalytical Clinical Operations Medical - Education Clinical Data Management Clinical Research Services HR Services Biostatistics Education &Staffing Services Corporate Training Medical Writing Certification Programs Pharmacovigil-ance Regulatory Affairs Quality Assurance Project Management

Bioanalytical Services At Jeevan, we have a state of the art facility equipped with advanced analytical instrumentation and an efficient workforce. We follow applicable GLP principles/regulations and SOPs. We work closely with our clients to identify their requirements and meet their expectations including cost and time constraints.

Bioanalytical Services BA/BE Clinical Phase I to IV MD/MV CUSTOMIZED SERVICES Bioanalytical services Tech transfer Preclinical ELISA

Bioanalytical: Facilities & Instruments State-of-the-art facilities: LC-MS/MS Systems HPLCs Deep freezers -200C and -800C Solid phase and Liquid-liquid extractor Temperature monitoring systems ELISA

We are committed to ensure patient rights, safety and data integrity. Clinical Operations Jeevan has the expertise to manage Bioavailability and Bioequivalence (involving healthy volunteers & patients) and Phase II to IV studies with qualified and trained workforce. We are committed to ensure patient rights, safety and data integrity.

Clinical Operations - Services Patients BA/BE Healthy Subjects Phase II - IV Clinical Operations CUSTOMIZED SERVICES PMS & OS Clinical Site Management Project Management

Clinical Operations - Capabilities Protocol writing Site identification and assessment Facilitate IRB/IEC application process Regulatory application process Project management Site initiation Site training and support Site monitoring Investigational product accountability 100% source documentation verification and data query clarification PK and statistics Report writing Site close-out

Clinical Data Management Services (CDM) Jeevan provides data management services by strict adherence to established operating procedures and apply quality standards and processes to complete large and complex clinical programs. Our systems are in compliance with applicable regulations / guidelines for managing data.

Data Handling and Cleaning AE & SAE Reconciliation CDM Services CRF Design Database Design Database Validation Data Collection CDM Services CUSTOMIZED SERVICES Data Handling and Cleaning Coding as per MedDRA AE & SAE Reconciliation QA and QC Database Lock Data Mapping Archival

CDM Service Overview Study Set Up Study Conduct Review Study Close Out QC and database audits Adverse Events Evaluation of medical & scientific consistence of data. Periodic review for protocol adherence, data recorded and regulatory file maintenance. Double data entry and Verification Data loading Data review and query Management SAE reconciliation Clinical Data Coding Interim data base closure QA/QC Database Lock Analysis and report CRF/e-CRF designing Data management Plan Database design and Set-up Import/Export set up Dictionary set up (MedDRA) CRF tracking setup

Jeevan services include pre-analysis, analysis and post-analysis. Biostatistics and Statistical Programming Services Jeevan clinical biostatistics services are comprehensive and can be tailored to meet the needs of client requirement. Jeevan services include pre-analysis, analysis and post-analysis.

Biostatistics and Statistical Programming Services Study Design Sample Size Calculation Scientific Inputs in Protocols CUSTOMIZED SERVICES Services SAP Development PK/PD analysis Statistical Report SAP Program & Interim Analysis Support for regulatory and advisory meetings

Overview Study Set Up Study Conduct Review Study Close Out Summarization of Study objectives Study subjects finalization Determination of sample size rational and power Description of statistical methodology Create and finalize programming process Finalize all planned tables, listings and Graphs Programming based on SAP or written specifications. Independent validation of project specific programming QA/QC validation of output results Creation of integrated databases Creation of tables, listings and graphs Exploratory analysis Summary of methodologies and results Prepare integrated Clinical/statistical report

Medical Writing Services Jeevan medical writing services provide a range of high-quality documents for all phases of product life cycle, from pre-clinical development through post marketing.

Medical Writing Services Pre Clinical Clinical CUSTOMIZED SERVICES Regulatory Submission Medical Writing Marketing Medical Education Scientific

~170 completed projects and 35 ongoing!! Medical Writing: Jeevan’s Accomplishments Since 2012: Metrics by Project Type ~170 completed projects and 35 ongoing!!

Pharmacovigilance Services Jeevan offers comprehensive pharmacovigilance and safety monitoring services from early development support through post-approval initiatives. Jeevan have experienced and skilled medical professionals with first-hand knowledge of regulatory requirements.

Pharmacovigilance Services Safety/Medical monitoring Medical review of data listings Review of medical coding data Literature evaluations CUSTOMIZED SERVICES Preparation of common technical document module II Pharmacovigi-lance Individual case safety reports Expedited reporting of serious adverse events AEs and SAEs logging, tracking, coding, case processing &distribution Periodic safety updates Safety analysis and benefit-risk evaluation Clinical safety reports Risk evaluation and mitigation strategies

Regulatory Affairs Services Jeevan provide expert services for the management of local regulatory issues with the regulatory authorities and fulfill client expectations in a realistic and transparent manner. Jeevan have in depth knowledge of the requirements of US FDA, EMEA, DCGI and other regulatory authorities, related to clinical development.

Regulatory Affairs Services Application for EC opinion Assistance in IEC/IRB application process Regulatory affairs Compilation of documents Preparation and Management of CT applications

Quality Assurance Services Jeevan offer the Quality Assurance services in GCP and GLP domains in-line with applicable GxP regulations. Quality assurance auditors are knowledgeable about local, national and international regulations, standards and guidelines.

Quality Assurance Services Investigator Site Qualification Audits CRO Qualification Audits Investigator site Quality Assurance Study Audits CRO Preparing investigator sites for inspection For Cause Audits

Project Management Services Jeevan provides end to end management of various phases of clinical research projects. Project manager serves as a primary resource and point of communication for the client and project team. Jeevan’s Project Manager provides leadership and direction to the team, including specification for time, quality and cost of deliverables.

Project Management Services Project Planning and Execution Resource allocation Site identification and assessment Contract Management Project Management Vendor Management Development of monitoring strategy Monitoring reports review and submission CRA training Proactive risk management

Why Jeevan

In a Nutshell Jeevan provides flexibility to meet client expectations and goals by providing solutions which are reliable and cost-effective

Contact Us Business contact: Address: Mr. Vasudev Sureddy Phone: +91-76590 11000 e-mail: vasudev.sureddy@jeevanscientific.com Address: Jeevan Scientific Technology Limited Plot No. 1&2, Survey No. 202 Sai Krupa Enclave Manikonda Jagir, Near Lanco Hills Hyderabad - 500 089 Telangana., India.

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