From accelerating success within R&D through to increased productivity, right-first-time quality, and regulatory compliance within manufacturing and clinical settings, CSols has been supporting the life sciences industries for more than 20 years. Through the provision of strategic planning, digital transformation, product selection, implementation, advanced data analytics, and validation services, CSols has been instrumental in helping our clients address their business challenges. Our experience spans the following industries within life sciences:
CSols has been supporting the drug discovery and development process within the complex and highly regulated pharmaceutical industry for more than two decades. The provision of lab informatics solutions to digitize the product lifecycle from R&D to production through quality control and assurance allows our clients to focus on the science that matters. Our data analytics team can help pharmaceutical clients optimize workflows and drug discovery programs, leading to improved decision making.
Biologics have become an increasingly important factor in improving human health. As new technologies, such as CRISPR 9 and novel antibody-based therapeutics, are developed the importance of biologics is continuing to rise. Although the end goal is the same as for traditional pharmaceuticals—the treatment of human disease—the method for discovery, development, and manufacture is not. CSols understands these differences and has deep experience in providing the appropriate solutions for large data sets with advanced data analytics.
Clinical labs testing human specimens operate under stringent regulations (e.g., CLIA) to ensure they provide accurate, reliable, and timely patient test results no matter where the test is done. CSols provides lab informatics and data analytics solutions for labs involved in kit assembly and distribution through to sample accessioning, biobanking and storage management, specimen analysis, and result delivery.
Research and manufacturing services are increasingly outsourced. Contract Research and Manufacturing Organizations provide drug discovery, development, cGMP manufacturing, biobanking, and aseptic fill and finish to the pharmaceutical and biotechnology industries. CSols provides lab informatics and data analytics solutions to CRO/CMOs, enabling more rapid and cost-effective development and scale-up of manufacturing.
Diagnostic advances, such as next-generation sequencing, have led to more rapid and precise understanding of disease pathways. CSols has been privileged to work with leading diagnostic companies that advance the detection of cancer and other high-morbidity conditions, leading to patient-centric treatment through advanced data analytics.
Whether a quality lab or a development lab, managing data in a medical device laboratory can be even more complex than in a traditional pharmaceutical laboratory. CSols has experience navigating regulatory and data analytics challenges in the medical device industry, especially with LIMS and ELN implementation and validation.