Clinical Data Management - Sclin Soft Technologies

1. Sclin Soft Technologies Sclin Soft Technologies is a USA based company, was established in 2015, which provides a full range of Clinical Operations, Clinical Data Management, Bio-statistics, Medical Writing and Programming Services on customer friendly business model. Sclin Soft Technologies closely works with the clients to access their needs and customize a business model tailor for satisfying their needs. Our experienced clinically and bio-statistics data management teams are committed to maintaining. The projects of our clients on time and within the budget by monitoring the quality and study of the data real-time performance and providing meaningful feedback to the project team. Sclin Soft Technologies data management team will provide a Customized, Cost effective and Flexible approach to meet the data management needs. Medical Writing: Medical writing is an integral part of clinical research. Our medical writers work closely with the multidisciplinary teams of the sponsor i.e, bio-statistic, pharmacological, project management and clinical data management teams to provide accurate, timely and inexpensive documents with ethical and scientific standards. Sclin Soft Technologies offers a complete range of medical writing services for regulatory submissions, scientific marketing materials in different therapeutic areas for all phases of the product from preclinical development to post-marketing literature. publications and medical-

2. Sclin Soft Technologies We guarantee the timely delivery of precise and regulatory-compliant documents to our sponsors in an affordable and flexible way. We organize our operations in integrated customer-centric units, to improve customer focus and to guide operational agility that can lead to delivery with quality, speed and value. The medical writers of the Sclin Soft Technologies team receive regular training to ensure uniformity with regulatory standards and to have consistency in writing processes. Our medical authors are scientists involved in the development of drugs that have the required scientific background, regulatory knowledge and professional attitude to be incorporated into the sponsor’s study teams during the clinical development process of a molecule. Medical Writing Services 1. ICH GCP compliant Clinical study reports(CSR) 2. IND, NDA, ANDA, MAA, CTA Regulatory submission 3. Clinical and non clinical segments of CTD 4. Investigators Brochure 5. Study Protocol 6. SOPs for all aspects of Drug Development process 7. Literature Review 8. Journal articles – Original research, Review articles, Editorials, case reports, etc. 9. Abstracts – Publication in journals and Submission to medical meeting 10.Posters Presentation at medical meetings FOR MORE INFO: https://www.sclintech.com/medical- writing/