At Solvdata we believe in providing high quality clinical data management to support your drug development needs to get drugs to market as quickly as possible. We provide bespoke solutions tailored to your requirements and provide real time, faster access to data meaning faster decisions can be made to keep patients as safe as possible. As a niche data-focused CRO, our expertise allows us to focus solely on the data of a clinical trial and enables us to develop trust with long lasting partnerships.
By concentrating exclusively on data we are able to offer efficient and flexible clinical data management services, we are seen as a niche provider for smaller teams or a valuable experienced partner for larger accounts. Our programming team’s diverse backgrounds and abilities allow us to handle difficult or non-standard studies with ease. Solvdata’s data management services include efforts prior to conducting a study as well as ongoing PK/PD-focused support during study conduct by our team of data managers. Your data are crucial. Data is the language through which sponsors communicate information about investigational drugs to regulatory authorities. All too often during clinical conduct, the importance of data are minimized and overlooked. Or, the nuances of collection, reporting, and querying of data are not fully appreciated by investigational sites.
What to Expect During the Study Design Phase:
In the study design phase, Nuventra works with your team to craft a well designed Phase 1 study that contributes to your drug development plan. Our experts evaluate regulatory feedback and your current drug program to identify any clinical gaps and assist in generating a study overview that adequately addresses your needs for the study, with a focus on pharmacokinetics, safety, and other potential pharmacometric endpoints.
Our experts have a broad depth of experience and can provide as much or as little assistance as is needed, including writing the protocol, generating regulatory compliant data sets, and submitting all data to the FDA.
Solvdata provides end to end comprehensive clinical data management services from Phase I through to post-marketing trials. Our team of global clinical data management experts are committed to upholding a standardized, process-driven approach.
