Services

Our Quality Service

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Clinical test management

clinical test management system Clinical Trail Management can involve thousands of people, hundreds of investigative sites, multiple CROs and various clinical source systems - all generating huge amounts of data. Our Clinical research associates overseas the each study of the clinical process to ensure proper planning, conduct, patient safety, data quality. Clinical test management is a site management which requires the maximum no. Of subjects. Our CTM is a powerful end-to-end clinical trial management solution that provides control, efficiency and quality data to every study For this process they require Clinical Research Associate (CRA) which takes a major part. CRA major work is to gather, collect and maintain all the subjects information manually. services: • Study document development • CRA Management and quality control • clinical monitoring and site management

Bio-statistics

The role of biostatistics is the key to the successful planning and execution of a development program. Bio Statistics are referred as extracting and clean the data. We can provide adequate advice for the calculation of sample size, randomization programs, statistical analysis plans (SAP), data interpretation and more. We are using bio statistics for Creation of Statistical Analysis Report. We are using different programming languages to extract the data which are mainly include Saas 4.4 base version and R programming language. For the analysis of data with softwares, we are using different tests like Z- Test, T-Test, chi square test. 

Data management system

The process of managing documents and other types of information such as images from creation, review, storage to its dissemination. It also involves the indexing, storage and retrieval of documents in an organized method. Services: • Improve the speed of your business by accessing and using information. • improve operational effectiveness with simplified processes. • Optimize your company's performance. • Management of incoming and outgoing documents, structured and unstructured data sources. • Reliable and secure archives • Scalable and robust easy to locate the right document.


Patent services

The purpose of patent services is to spread the knowledge and importance of opportunities in identification, intellectual property and regulatory affairs and to cultivate the culture of these assets in an organization to create brand value for the organization. We are experts in patent filing, i.e. intellectual property in the areas of chemical, pharmaceutical, ethical and generic products, software and hardware, etc. These intellectual properties are intangible assets that maximize the generation of revenue through the correct and effective exploitation of the knowledge acquired. Services: Regulatory consultant for medicines, pharmaceutical products, veterinary medicines, medical devices and food supplements • Submission of the patent (Indian and global) • PCT is archiving • Preparation of ANDA certifications for USA, CA, AU. • brands • Copyright • Drawings

Clinical data management

Sclin Soft Technologies has extensive experience in providing clinical data management services. Our data team plays a key role in every clinical trial, from the design of the electronic form (CRF) to the timely delivery of quality data for statistical analysis. Our team guarantees the completeness, accuracy and reliability of the data so that they meet the quality standards estimated for reporting to regulatory bodies. Clinical data management is the process of computing, analyze and clean the data by using different data bases like MS-Access, Rave meta data. It also involves the indexing, storage and retrieval of documents in an organized method. We are using two different services for managing our data. I.e., data management paper based, data management EDC studies. OUR PAPER BASED SERVICES: • Study Setup Activities • CRF design • Database setup • Double Data Entry • Data Quality Check • Discrepancy Management • Data Loading • Database Transfer & Lock

Medical writing

Medical writing is an integral part of clinical research. Our medical writers work closely with our colleagues in the bio statistic, pharmacovigilance, project management and clinical data management teams to provide accurate, timely and inexpensive documents to the highest ethical and scientific standards. Sclin Soft Technologies offers a complete range of medical writing services for regulatory mailings, scientific communications and medical-marketing materials in different therapeutic areas for all phases of the product life cycles, from preclinical development to post-marketing literature.

We guarantee the timely delivery of precise, regular 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 uniform uniformity with regulatory standards and to have consistency between 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.

OUR MEDICAL WRITING SERVICES:
• Journal articles - Original research, Review articles, Editorials, case reports, etc.
• Abstracts- Publication in journals and Submission to medical meetings
• Posters Presentation at medical meetings

Back file document conversion

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Customized solutions

Sclin Tech specializes in providing on-site, long-term and part-time consultancy and support services on a contractual basis to all our customers. We provide expert services in the areas of end user training, documentation and production support. Sclin Tech also offers full implementation services to our customers. We offer an initial assessment process, an analysis of the adaptation gap, an approach to industry best practices, pilot session projects, construction, testing, training, launch and post-go-live production support. With Sclin Tech, you get one of the most dedicated, innovative, flexible and technologically advanced resources that will help you with the best practices and approaches in the sector during your implementation phase. During our initial assessment, we present our customers with all options including software gaps, impacts on your organization, impacts on current policy and procedure, security issues, audit and control considerations, alternative solutions.