Sanjeevani

COMPANY PROFILE

Sanjeevani, IVth Floor, Surekha Chambers, Near Lalbungalow, Ameerpet, Hyderabad- 500016, AP, India Ph.No: +91-40-66026606; Email: info@sanjeevaniservices.com; Web: www.sanjeevaniservices.com

Company Overview Sanjeevani is a contract research organization (CRO) headquartered in Hyderabad, AP, India, specializing in Clinical Operations, Medical writing, Drug Safety and Pharmacovigilance, Biostatistics, SAS programming, and Data management services. SANJEEVANI has been working with a wide range of pharmaceutical and biotechnology companies as well as research institutes since 2009. At Sanjeevani, we understand that your trial needs are unique, so we offer the comprehensive services and experience of a large CRO with the personalized attention you deserve. Our staff is comprised of academically and industry-trained professionals with the hands-on experience, problem-solving skills and dedication necessary to assist you in the development and implementation of your trial. Sanjeevani provides technology and services that enable the pharmaceutical, biotechnology and medical device industries to collect, interpret and distribute clinical data more efficiently. The Company offers Data management and Data analysis services, which are used by pharmaceutical companies, biotechnology companies, medical device companies, clinical trial sponsors and clinical research organizations (CROs) during the conduct of clinical trials. What We Do Clinical Data Consulting is the discipline of ensuring the successful collection, integration, and analysis of ALL data related to the clinical trial. This includes study build and support, custom application development, customized report and SAS dataset design and creation, and integration of clinical data with ERP and other data collection systems. Most clinical trial managers and CROs only focus on data collection objectives rather than data analysis and study outcome objectives - including planning for the integration of data. Trial data needs may not be fulfilled by a Clinical Data Management System (CDMS) alone. Sanjeevani offers a coherent data strategy that consists of a coordinated process of Clinical Trial Coordination, Clinical Data Consulting, and Outcome Management Services to produce valid trial data.

Clinical Trial Coordination is the methodology of ensuring the trial is set-up correctly in the early stages of the trial. Our efforts begin with developing a strategy from trial design and trial management by analyzing the protocol and developing the Data Management Plans (DMP) and Standard Operating Procedures (SOP), as well as training all members. Although Clinical Trial Coordination begins at study start, it is continued throughout the course of the study by maintaining the processes. Our Comprehensive Approach Produces Better Data This holistic approach identifies potential problems and opportunities upstream, before data-based decisions must be made, and downstream, in anticipation of the next trial phase. As a result, you obtain pure, clean data that supports your research. Any CRO can collect, store and manage data. But if that data isnt high quality, your entire trial could be in jeopardy. This is where Sanjeevani can help you reach the next level. Our work starts before the database development and data collection process begins. We analyze your protocol in order to design and implement CRFs, Data Validation Specification, eCRF Specification, Data Management Plans and SOPs. After we have completed an analysis of your study requirements, we develop a comprehensive and coordinated data strategy that integrates all data sources and trial conduct management. With Sanjeevani, you eliminate the high costs of poor quality data, redundant data clean-up efforts and, in worst case scenarios, a failed trial. Just as importantly, when we manage your trial data, you have more time to focus on research and critical macro-level decisions for your company. Our Dedication to Customer Service Results in More Successful Trials Our dedication to customer service sets us apart from other CROs. Good customer service is an integral part of our value proposition, which combines our service offerings, our performance, and our pricing. We provide answers to your needs while providing a cost-effective and strategic solution in a timely and professional manner. Ultimately, with Sanjeevani as your trusted CRO partner, you not only obtain better quality data, minimize costs and save time, you achieve more successful trials. Clinical research is the study of new therapies and/or medical devices and better ways of using current medicines which may improve treatment or prevention of a disease. Participation by patients and physicians is essential for the development of new drugs and medical devices. Several trials may take place over a period of time until a new drug or device is approved and becomes available to our patients by prescription. New treatments and medications developed by researchers are carefully tested; safety for each and every patient is our primary concern, and is guided by strict U.S. Food and Drug Administration (FDA) regulations.

SANJEEVANIs Expertise Services:

Site Recruitment and Management

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. Services include: Site telephone interviews to determine interest, availability & expertise Preparation of letters of confidentiality, conduct qualification visits and formal evaluation reports Investigator Meeting support Orientation / initiation visits, including verification and collection of regulatory documents and discussion of trial parameters Interim monitoring visits, including source data verification, IRB / SAE document review and CRF corrections Ongoing trial site management Close-out visits, including final binder review, final drug accountability / return and review of study Documentation 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.

Medical Writing
Sanjeevanis experienced team of medical writers will prepare regulatory documents in accordance with the specific guidelines and standards as recognized by the industry and FDA. Our team can assist you with: Study reports Integrated clinical trial reports Scientific posters and papers

 Clinical manuscripts to support marketing and journal publications

Data Management
Sanjeevani employs traditional methods as well as internetbased solutions to prepare your CRF and ultimately manage the collection, QC and QA of the data during the trial. CRF and eCRF design Data management plan development Data collection system development, including database design, programming, validation and system maintenance CRF processing, including tracking, double data entry and verification Electronic data collection Data cleaning / Quality Assurance, including edit checks, query resolution and documentation of corrections Reconciliation of external data Medical coding

Drug Safety & Pharmacovigilance

Timely and accurate information is critical when making decisions affecting human life. Sanjeevani offers both traditional and internetbased solutions to expedite the reporting and tracking of adverse events / serious adverse events. Services include: Development of safety databases Coordination with regulatory and clinical stakeholders Medical review and coding of Adverse Drug Reaction Reports Risk signal detection and evaluation Action Plan development for safety risks Narrative writing Regulatory reporting and submissions CIOMS, MEDWATCH, PSURs, expedited reporting

 Biostatistics
Data, processed rapidly and with accuracy, becomes information upon which conclusions are based. Sanjeevani utilizes the appropriate tools to evaluate information on an ongoing basis thereby allowing the availability of statistical results shortly after LPLV. Sanjeevani will: Develop the Statistical Analysis Plan Provide sample size determinations and power calculations Perform statistical analysis, including SAS dataset creation, SAS program development and all required testing and validation. Create a complete data package with validation of tables and listings Provide scientifically sound interpretation and reporting of results Provide clients with remote access to data for analysis

Patient Registry
Sanjeevanis proprietary and customizable technology assists with new product launches as well as post marketing support programs to assess performance, outcomes, safety profile confirmation and market segmentation. Sanjeevani will support your registry needs through: Strategy development Registry protocol development eCRF development, including Quality of Life questionnaires Physician recruitment and management Statistical evaluation of economic and clinical outcomes Data collection and management Manuscripts for publication

Dedication and Experience: Sanjeevani is dedicated to the success of your study and to providing the highest quality of service. Sanjeevani employs documented and time-proven processes to manage your project tasks, timelines, resourcing and budget. All of our services are performed in accordance with our rigorous SOPs and in compliance with ICH / GCP guidelines and 21 CFR Part 11. Our experienced staff will work closely with your team to understand the requirements of your development program and will ensure that the right team is put into place to accomplish the tasks at hand. From the start of project discussions, Sanjeevani will draw upon the expertise of industry opinion leaders and will form expert panels with the necessary therapeutic experience to provide consultation and input into the design of the study. When you partner with Sanjeevani you will benefit from our: Experience with risk mitigation programs / strategies established prior to the start of any project Ability to assign the appropriate project team for any given study Global capabilities, including India and Europe Organizational structure which results in lower costs than a large CRO Clinical expertise across numerous indications, extensive scientific backgrounds, and regulatory and marketing experience Let us assist you with your next clinical program...

Contact us:

Sanjeevani
IVth Floor, Surekha Chambers Near Lalbungalow, Opp.Vijay Textiles Ameerpet, Hyderabad-500016 Ph.No: +91-40-66026606, 07, 08, 09, 10 Email: info@sanjeevaniservices.com Web: www.sanjeevaniservices.com