Clinical Research Strategies, LLC
Clinical Research Strategies (CRS) is a CRO and executive management consultancy for life sciences start-ups and mid-size companies with a functional service provider model. Indications include precision medicine, oncology, immunoncology, regenerative medicine, CNS, digital therapeutics, orthopedics, cannabinoids, respiratory, critical care, surgery, renal insufficiency, infectious diseases, across drugs, biologics and medical devices including SaMD and SasS. Team members are well versed in all phases of research with many years of experience working in sponsors, CROs, and research sites.
Presagia comprises leading experts with multi-disciplinary expertise in data science, predictive and statistical modeling, clinical science, and drug development. Its precision analytics platform integrates machine learning with biomedicine. Presagia collaborates with biotech, pharma and CROs to use machine learning to gain data insights into pharmaceutical product safety and efficacy, and to aid decision-making regarding clinical trial design and conduct. The applications of the methodology include optimal patient selection, trial monitoring, endpoint selection, study design decisions and insights from master-protocol settings, and biomarker selection. Presagia analytical toolkit have been devised, studied, and published in peer-reviewed academic journals and applied to disease areas including oncology, autoimmune, and neurological disorders.
Stat4ward LLC provides statistical consulting services to pharmaceutical, medical device, and diagnostic companies with a focus on companion diagnostics (Pre-sub, PMA), biomarkers, CMC, and IVD/LTD product assay validation and submission. Stat4ward is comprised of a team of statisticians who have deep experience in applying non-clinical and clinical statistics methodologies to pharmaceutical and IVD/LDT development. The services include study design, planning, execution and interpretation of data analysis, data-enabled critical decision making for product development, regulatory submissions, FDA interactions, and publications.