Case Study 1 (2013)
AccuClin staffs were embedded into an internal team of a CRO to work with the Project Manager to address and resolve outstanding queries in a longitudinal clinical database. With AccuClin’s support, all queries and outstanding database issues were quickly resolved and brought to a timely closure allowing the clinical data to be delivered on time for research analysis and commercial publications.
Case Study 2 (2013)
A development-stage biopharmaceutical company in the US requested through subcontract that AccuClin help with accelerated development of two EDC databases in a highly restricted timeline. AccuClin rapidly developed, validated and deployed the EDC databases — from CRF design to edit checks — for both studies in time to meet the client’s tight patient enrollment schedule. Since then, data for both studies have been successfully received, cleaned and databases locked with no interruption in client timelines.
Case Study 3 (2014)
A global specialty healthcare company needed urgent assistance of their Phase I study analysis from an external partner as part of an NDA. For this project, AccuClin successfully provided all SAS outputs with complete PK/PD parameters and CDISC data sets on time which were critical for this NDA submission.
Case Study 4 (2014)
Provided full statistical support to a CRO, completed activities included statistical contributions in protocol review, budget estimate, RBM guidance, SOPs development and bid defense.
Case Study 5 (2014)
Contracted responsibilities for programming, data analysis, output processing, and preparation of all data files for Abbreviated New Drug Application (ANDA) submissions for specific products, including PBE analysis and preparation of required tables, listings, and graphs.