Securely managing large quantities of data may get a lot of attention lately, but it is nothing new to clinical trials. We combine processes, technology and expertise to quickly and efficiently make sense of the mountains of clinical data, packaging it to fit the needs of our customers.
We support customers in developing the Data Management Plan and database design, incorporating the latest technology to automate and optimize processes, eliminate bottlenecks, reduce errors and manage even the largest and most complicated trials. Following Good Clinical Data Management Practice (GCDMP) guidelines, we focus on every detail, from the design of the case report form to ensuring quality in data coding and data entry.
Through our flexible delivery model, we work across time zones with in-depth knowledge of each market. Paired with extensive training and adherence to confidentiality beyond HIPAA, we ensure data is reliable and secure. With a focus on quality, we go beyond validating data, logging errors and managing discrepancies. We collaborate with monitoring teams to avoid errors. After thorough validation and database locking, our teams work seamlessly with medical writing and medical affairs specialists to analyze, package and report results for regulatory approval.
Taking a consultative approach from the start, we work with each customer’s SOPs and work to find better and more efficient ways to implement them. With a focus on supporting the needs of each trial, rather than forcing each trial to fit a pre-existing structure, we are able to be more flexible and find greater efficiencies, making data management faster and more reliable.