Resolutum Global is a biometrics clinical research organization that focus on clinical study data collection, analysis, and reporting. We specialize in early phase clinical trials and provide support from protocol development to clinical study report (CSR) writing using purpose-built systems and processes. Our team has international and local clinical trials experience gained through working in CROs, pharmaceutical, and biotechnology companies. Individually, each team member has at least 15 years’ experience and collectively the company has over 60 years’ experience to serve our customers. Using a leading EDC solution, we optimize the data collection process and support risk-based monitoring for efficient data collection with reduced source data monitoring load on the site(s) and sponsor. Resolutum Biostatistics team provides sample size calculations, generates study randomization, prepares statistical analysis plans, data analysis, and provides CDISC–compliant SDTM and ADaM data packages. Our medical writers support our customers from protocol development to CSR writing. Resolutum implements tailored solutions for our customers to successfully complete their studies in time cost-effectively.
