CliniOps offers comprehensive data services to augment your in-house team, or the services provided by your CRO partner, throughout study startup, study conduct and study closeout phases. During study startup, our experienced configuration team supports the study build including configuration of forms, edit checks, workflows, reports, notifications et al., across all modules. A complete validation is also performed with CRF completion guidelines and release notes. During the study conduct phase, clinical data management, query resolution, user management and standard support services are provided. In addition, data reconciliation, DB lock, data transfer, data archival and other services are provided during the study closeout phase. Post that, CliniOps also provides, Biostatistics, TLF programming, ADaM, SDTM, and medical writing services.
CliniOps offers a comprehensive study setup services. Our customized services are designed to help you configure your trials more efficiently. We will not only complement your internal team to achieve your goals but will also ensure transparency and collaboration through out the duration of your trial. Subject-matter experts who have experience with everything from simple single arm studies to complex multi-arm randomized global studies will form the core of the study setup team and will ensure that real-world issues are taken into account. We ensure timely study build cycles with early review phases and testing opportunities. In fact, before we provide you your study for User Acceptance Testing, it will go through a rigorous quality assurance and clinical review cycle.
Our team of experienced professionals can help you in all aspects of clinical data management challenges and collaborate with you in the process of collection, cleaning, and management of subject data in compliance with regulatory standards. Our goal is to provide you with error free, valid and statistically sound data for analysis. Our clinical data management specialists will translate your clinical trial protocol into an intuitively designed data capture system that will accurately meet the data capture requirements of your study. So, while our team of professionals manages all your data, you spend less time on training and more time running the trial efficiently. With continuous access to your data and total transparency in the entire process, you stay in complete control of your data.
At CliniOps we offer you high-quality, cost-effective, best in class biostatistics services. We have rich experience in biostatistics analysis & reporting. Our biostatistics services offer you accurate data analysis and the ability to comply with regulatory requirements. Our services include Trial Design, Randomization, Statistical Analysis Plan (SAP), Statistical Programming, Tables, Listings and Figures (TLFs) and Clinical Study Report (CSR) generation. We have extensive experience in designing, analyzing and reporting clinical studies across a broad range of therapeutic areas, supported by robust processes. Our deep regulatory knowledge & domain expertise in biostatistics services helps you to navigate the complexities of study design, calculation of sample sizes, study randomization, Data Visualization etc.