Biostatistics
SCL IT' team of biostatistics and statistical programmers bring decades of expertise in operational and strategic statistics. This is considered as vital for every aspect of drug development. Some of our preferred biostatistics services include Power analysis, randomization plans, definition of populations, Statistical analysis of data, creation of SAPs and TLFs, interim analysis plans, statistical reports and DSMB support.
CRO Services
SCL IT' full-service contract research organization (CRO) services are built on high level of collaboration and flexibility. We take care of the local regulatory requirements through our proven CRO expertise and therapeutic leadership. Our team brings decades of experience to overcome the most difficult industry challenges across all major therapeutic areas. We establish the new and innovative models in clinical research with a lasting impact on the future of health care.
Statistical Programming
The process of getting a drug to market requires an inordinate amount of clinical data analysis. Our statistical programmers bring a deep understanding of life sciences, so they play a key part in the clinical process.
SAS Programming
Our SAS programming team performs a crucial role in collecting and analysing clinical trial data about a medication. Importantly, they are concerned with promoting research and evaluating the side effects and costs.
CDISC services
CDISC or Clinical Data Interchange Standards Consortium is a standards developing organization (SDO) dealing with medical research data linked with healthcare. Significantly, CDISC enables information system interoperability to improve medical research and related areas of healthcare. SCL IT upholds CDISC norms and standards to create clarity in clinical research. This also means to bring together a global community of experts to develop and advance data standards of the highest quality.
SDTM Programming
We deploy clinical data standard models such as the CDISC SDTM or company specific standards within the organization which can be leveraged by all users. By this there is no need of developing additional metadata libraries or programs. The basic objective of SDTM programming is to help users to organize, standardize and manage clinical research data and metadata in compliance with CDISC SDTM or company specific internal standards.
ADaM Programming
As understood, ADaM defines dataset and metadata standards that support efficient generation, replication and review of clinical trial statistical analysis etc. SCL offers end-to-end support on ADaM that will help in easy submission of clinical trials and analysis results to Food and Drug Administration (FDA).
Pinnacle 21
SCL IT offers end to end data standardization services. We ensure that your study data and supporting documentation are compliant with FDA's requirements and ready to support the regulatory review process. By adhering with Pinnacle 21 standards we help in managing CDISC compliance, clinical data quality, and FDA submission readiness.
Define XML
CDISC's requirement of an XML-based metadata document introduces new challenges to Programmers in the pharmaceutical Industry. As understood, the CDISC Define.xml file is central to any electronic FDA submission. SCL IT leverages on OpenCDISC Enterprise 2.5 to create FDA-compliant Define.xml 2.0 files in a snap. This enables easier transmission of metadata for CDISC SDTM, SEND and ADaM datasets and also allows for faster time to market.
Welcome to SCL IT
SCL IT is your value-driven, full-scale, and integrated biopharmaceutical solutions partner. Our collaborative working models help bringing greater coordination between different disciplines. Significantly, this means to bring new therapies to market, and rapidly bridging clinical performance to commercial success. We work together with our clients to create customer success, exponentially.
SCL IT leverages on its unique bio-pharma model which is repeatable, predictable, and highly reliable. We can deliver value to small, medium and large bio-pharma industry and meet critical development milestones with greater ROI and far lesser TAT. Also, we optimize engagement of medical and patient communities after product approval.
Head Office : 4 Ambassador Place, Stockport Road, Altrincham, United Kingdom, WA15 8DB
+44 (0) 161 883 3193info@sclit.co.uk
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