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Sanjeevani Life Sciences


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Sanjeevani Life Sciences

  1. 1. Quality, Reliability & Confidentiality
  2. 2. Company Overview <ul><li>Contract research organization (CRO) specializing in Clinical Operations and Data management services. </li></ul><ul><li>SANJEEVANI has been working with a wide range of pharmaceutical and biotechnology companies as well as research institutes since 2009. </li></ul>
  3. 3. Company Philosophy SANJEEVANI is committed to maintain 100% client’s satisfaction by certain values
  4. 4. Our Team
  6. 6. Clinical Research Our database of key investigators and opinion leaders, organized by therapeutic and geographic area, will expedite your site screening and selection process. Once sites are selected for participation, Sanjeevani offers a full range of site initiation and management services to ensure your study runs smoothly..   Our work force department include Site Recruitment and Management : In addition to the traditional monitoring activities, Sanjeevani also offers internet-based remote site monitoring. This reduces the number of required site visits and allows us to monitor site performance and documentation 24 hours per day, 7 days per week. More……..
  7. 8. Clinical Data Management <ul><li>Sanjeevani employs traditional methods as well as internet- based solutions to prepare your CRF and ultimately manage the collection, QC and QA of the data during the trial. </li></ul><ul><ul><li>CRF and e CRF design. </li></ul></ul><ul><ul><li>Data management plan development. </li></ul></ul><ul><ul><li>Data collection system development </li></ul></ul><ul><ul><li>including database design, programming </li></ul></ul><ul><ul><li>validation and system maintenance. </li></ul></ul><ul><ul><li>CRF processing, including tracking, </li></ul></ul><ul><ul><li>double data entry and verification. </li></ul></ul><ul><ul><li>Electronic data collection. </li></ul></ul><ul><ul><li>Data cleaning / Quality Assurance, </li></ul></ul><ul><ul><li>including edit checks, resolution </li></ul></ul><ul><ul><li>and documentation of corrections. </li></ul></ul><ul><ul><li>Reconciliation of external data. </li></ul></ul><ul><ul><li>Medical coding. </li></ul></ul>
  8. 9. Data Analytics <ul><li>Sanjeevani utilizes the appropriate tools to evaluate information on an ongoing basis thereby allowing the availability of statistical results shortly after LPLV. </li></ul><ul><li>Sanjeevani : </li></ul><ul><li>Develop the Statistical Analysis Plan </li></ul><ul><li>Provide sample size determinations and power calculations </li></ul><ul><li>Perform statistical analysis, including SAS dataset creation, SAS program development and all required testing and validation. </li></ul><ul><li>Provide scientifically sound interpretation and reporting of results </li></ul><ul><li>Provide clients with remote access to data for analysis </li></ul><ul><li>  </li></ul><ul><li>SAS Consulting: </li></ul><ul><li>Sanjeevani provides SAS consulting services in the area of Technical Specification Development, Project Management, Statistical Analysis, Code Review, Data Mart and Warehouse Design. More….. </li></ul>
  9. 10. Drug Safety & Pharmacovigilance <ul><li>Timely and accurate information is critical when making decisions affecting human life. Sanjeevani offers both traditional and internet- based solutions to expedite the reporting and tracking of adverse events / serious adverse events. </li></ul><ul><li>Services include: </li></ul><ul><ul><li>Development of safety databases </li></ul></ul><ul><ul><li>Coordination with regulatory and clinical stakeholders </li></ul></ul><ul><ul><li>Medical review and coding of Adverse Drug Reaction Reports </li></ul></ul><ul><ul><li>Risk signal detection and evaluation </li></ul></ul><ul><ul><li>Action Plan development for safety risks </li></ul></ul><ul><ul><li>Narrative writing </li></ul></ul><ul><ul><li>Regulatory reporting and submissions - CIOMS, MEDWATCH, PSURs, expedited reporting. </li></ul></ul><ul><li>More…. </li></ul>
  10. 11. Medical Writing Sanjeevani experienced team of medical writers will prepare regulatory documents in accordance with the specific guidelines and standards as recognized by the industry and FDA. More….. We Offer: <ul><ul><li>Drug brochures </li></ul></ul><ul><ul><li>Investigator's brochures </li></ul></ul><ul><ul><li>Clinical study reports </li></ul></ul><ul><ul><li>Data presentations </li></ul></ul><ul><ul><li>Risk assessment reports </li></ul></ul><ul><ul><li>Scientific information brochures </li></ul></ul><ul><ul><li>Pharmaceutical/ regulatory documents </li></ul></ul><ul><ul><li>Patient diaries </li></ul></ul><ul><ul><li>Briefing Documents </li></ul></ul><ul><ul><ul><li>Clinical Study Reports </li></ul></ul></ul><ul><ul><ul><li>Protocol Development </li></ul></ul></ul><ul><ul><ul><li>Standard Operating Procedures </li></ul></ul></ul><ul><ul><ul><li>Summaries of Product Description </li></ul></ul></ul><ul><ul><ul><li>Abstracts </li></ul></ul></ul><ul><ul><ul><li>Scientific Literature Reviews </li></ul></ul></ul><ul><ul><ul><li>Clinical papers </li></ul></ul></ul><ul><ul><ul><li>Scientific research papers </li></ul></ul></ul>
  11. 12. Pharmaceutical Validation <ul><li>Sanjeevani establish and execute programs covering all phases of validation for all products, equipment, and processes. We develop process and/or equipment protocols for formulation, labeling, filling, and packaging for all products, including all support systems. </li></ul><ul><li>Sanjeevani assures full compliance with cGMP’s and other related requirements. We collect, collate and analyze validation data and prepare final validation reports for approval. Sanjeevani reviews data, validation protocols, and report. </li></ul><ul><ul><ul><li>Validation Master Plan and Support </li></ul></ul></ul><ul><ul><ul><li>Process Validation and Support </li></ul></ul></ul><ul><ul><ul><li>Quality Control and Quality Assurance </li></ul></ul></ul><ul><ul><ul><li>Drug Life Cycle Validation and Support </li></ul></ul></ul><ul><ul><ul><li>GxP Validation and Support </li></ul></ul></ul><ul><ul><ul><li>Risk Assessment and Validation for Life science Projects. </li></ul></ul></ul><ul><ul><ul><li> More…… </li></ul></ul></ul>
  12. 13. Toxicity Studies
  13. 14. Therapeutic Areas
  14. 15. Team Profile Sanjeevani team with high acumen are organized in different sectors as per their experience and caliber. CLINICAL RESEARCH RESOURCE NUMBER YEARS OF EXPERIENCE Clinical Research Coordinator 15-20 0-2 yrs Clinical Research Associate 4-6 1-3 yrs Internal Auditor 1-2 2-4 yrs Medical monitor 1-2 3-5 yrs Investigators 50+ Varies Clinical Trial Assistant 1- 1-2 yrs Clinical Operations Manager 3-5 3-5 yrs Project Manager 2-4 3-5 yrs Medical Writer 4-6 2-4 yrs
  15. 16. Team Profile CLINICAL DATA MANAGEMENT DEPT. PHARMACOVIGILANCE DEPT. RESOURCE NUMBER YEARS OF EXPERIENCE Database Executive 6-8 1-2 yrs Clinical Data Management Associate 8-10 2-4 YRS CDISC 3-5 3-5 yrs Project Manager 2-4 3-5 yrs Investigators 50+ Varies RESOURCE NUMBER YEARS OF EXPERIENCE Drug Safety Associate 3-4 2 yrs Drug Safety Inspector 2-3 4-6 yrs Medical Reviewer 2-3 2-4 yrs
  16. 17. Team Profile DATA ANALYTICS DEPT. PHARMACEUTICAL DATA VALIDATION DEPT. RESOURCE NUMBER YEARS OF EXPERIENCE Jr.SAS Programmer 3-5 1-2 yrs Sr.SAS Programmer 3-5 2-4 yrs Biostatistician 2-4 2-4 yrs Team Lead 1-3 2-4 yrs Project Manager 1-3 4-5 yrs RESOURCE NUMBER YEARS OF EXPERIENCE Subject Matter Expert 4-6 Varies Testers 4-7 3-5 yrs Process Executives/Consultants 7-8 2-4 yrs
  17. 18. When you Partner Sanjeevani
  18. 19. Additional Slides
  19. 20. Our Medical Writing Services Pre-submission documentation: : Clinical study protocol Investigator brochures Patient informed consent forms Investigational New Drug Application (IND) Post-submission documentation: : Clinical study report (CSR) Integrated summary of safety and efficacy Common technical documents (CTD), other formats Premarketing and post-approval annual reports Phase I-IV integrated clinical statistical reports (ICSR) Scientific / medical communication: : Literature reviews Posters, abstracts, and manuscripts Presentations Educational material Marketing and training material
  20. 21. Pharmaceutical Validation Services <ul><li>Regulated Industry Compliance Audits </li></ul><ul><ul><li>Vendor, Supplier, Contractor, Consultant, Audits. </li></ul></ul><ul><ul><li>‘ Due-Diligence’, ‘For-Cause’ & 483 Site Remediation </li></ul></ul><ul><ul><li>Mock FDA Audits and Pre-Audit Preparations </li></ul></ul><ul><ul><li>GMP – API – GLP – GCP – ISO – ICH – OECD – Ethical – OTC – Manufacturing – R&D </li></ul></ul><ul><li>Computer Systems, Part 11 ERES, IT, MIS Services, EDC, Clinical Systems and Data Capture </li></ul><ul><ul><li>Quality Assurance, Part 820 QSR, QSIT, ISO 14971, ICH 13485, ISO 9xxx </li></ul></ul><ul><ul><li>GMP Good Manufacturing Practice Audits (21 CFR Part 210/211, ISO, ICH Q7A) CAPA Management Programs and Methodology. </li></ul></ul><ul><ul><li>GLP Good Laboratory Practice Audits, 21 CFR Part 58, CLIA, OECD, Engineering, Facility & Validation, ISO 17025, Canadian 1510e Standard. </li></ul></ul><ul><li>GCP Good Clinical Practice Audits </li></ul><ul><li>Computer System Validation, Engineering, Development & Protocol Execution Audits </li></ul><ul><li>21 CFR Part 11 Site(s) Remediation Initiative Project Management. Global Standardization </li></ul><ul><li>Project Engineering – Pharmaceutical Facilities, Manufacturing / R&D </li></ul><ul><li>Facility Project, Maintenance, Engineering & Quality Management & Procedural Development </li></ul><ul><li>On-Site Training and Development. </li></ul>
  21. 22. Pharmacovigilance Services… <ul><li>SAE/AE Handling </li></ul><ul><li>Adverse event (AE) and serious adverse event (SAE) data entry and logging </li></ul><ul><li>Current treatment utilization patterns </li></ul><ul><li>Disease burden and prevalence </li></ul><ul><li>Data Management </li></ul><ul><li>AE and SAE logging, tracking, coding and case processing </li></ul><ul><li>MedDRA and WHO-DD coding </li></ul><ul><li>Medical Analysis </li></ul><ul><li>AE and SAE evaluations </li></ul><ul><li>SAE narrative writing </li></ul><ul><li>Physician medical review and signal detection </li></ul><ul><li>Literature reviews and summaries </li></ul><ul><li>Regulatory Reporting </li></ul><ul><li>Generation of Med Watch 3500A/CIOMS I forms </li></ul><ul><li>Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs) </li></ul><ul><li>Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports </li></ul><ul><li>  </li></ul>
  22. 23. Toxicity Studies… Making a Drug to the market is a long and complex process that requires a knowledge intensive work and a multidisciplinary team. Sanjeevani's aim is to help you with the non-clinical research throughout the development of the product. Sanjeevani offers regulatory-level toxicology studies conducted under GLP standards. Protocols are designed according to sponsor’s strategy for preclinical development and in compliance with guidelines issued by international regulatory bodies (EMEA, FDA, OCDE, ICH…) and Local Regulatory Board (DCGI, CDSCO). Sanjeevani experts take care of providing the non-clinical studies required for the registration dossier of the product.   We offer a wide range of experimental models in toxicology in which we can perform repeated dose protocols through different routes and up to different durations. Kind of Studies:  
  23. 24. SAS Consulting Services…. Sanjeevani provides SAS consulting services in the area of Technical Specification Development, Project Management, Statistical Analysis, Code Review, Data Mart and Warehouse Design. Our comprehensive consulting services include: Research question definition - helping your organization determine what it really needs to know. Study design - developing a research plan that will produce valid, reliable answers. Sampling - determining sample size, criteria for inclusion and sampling methodology. Survey/data collection instrument design - developing surveys, medical record abstraction tools or other forms to collect the required data. Data collection - identifying and acquiring existing databases or, more commonly, developing data &quot;from scratch&quot; using a variety of collection methods including: medical record reviews, surveys, focus groups, interviews, data tracking sheets, review of legislation and internet research. Report preparation - creating clear, comprehensive reports Planning activities - organizing meetings, task force leadership and other activities to help you assess our recommendations and select your course of action. Follow-up studies - tracking the results of changes implemented in response to recommendations
  24. 25. Clinical Reseach Services…. <ul><li>Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including Pharmacodynamics & pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug. </li></ul><ul><li>  </li></ul><ul><li>The Experts at Sanjeevani can handle global clinical trial programs. Sanjeevani expertise includes medical devices, therapeutic area, regulatory, and clinical operations. We are known for helping our clients attain greater resource efficiencies, shortened development times and broader market access while bringing safer, more effective treatments to the patients.. </li></ul><ul><li>  </li></ul><ul><li>The Company has Expert Research Professionals working on various drug products. Our work force departments include: </li></ul><ul><li>Site Feasibility and Investigator selection </li></ul><ul><li>Clinical Data Management </li></ul><ul><li>Pharmacovigilance </li></ul><ul><li>Data Analytics with SAS </li></ul><ul><li>Regulatory Affairs </li></ul>