Study Setup 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.

Protocol Development | CliniOps

Protocol Development

  • We offer comprehensive protocol development services utilizing our extensive and cross-functional scientific expertise.
  • We form an early partnership with clients to ensure development of an executable trial with minimal protocol amendments.
  • Our expertise in regulatory affairs and knowledge of acceptable endpoints increases the probability that our protocols will be accepted by regulatory agencies across the world.

eCRF and ePRO Configuration

  • Our experts will take care of your complicated electronic data collection forms, design branching questions, and develop in-form and cross-form validations and edit checks to maximize data cleaning at the field level.
  • Our product also offers a library of forms in various therapeutic areas which are CDASH and CDISC compliant as per industry standards.
  • We also provide configuration support for multi-lingual eCRF forms, and any localization support needed to configure the application workflow to align with the site’s local processes.
eCRF and ePRO Configuration | CliniOps
Edit Checks & Data Validation | CliniOps

Edit Checks & Data Validation

  • We work closely with sponsors to determine and document the checks, appropriate code lists, and the procedures that will be used for invalid results.
  • We implement and test the checks and codes in the clinical database management system.
  • Checks are run real time during data entry or at intervals and invalid results are fixed.

Interactive Response Technology (IRT) setup & Configuration

  • Our IVRS/IWRS integrations provide real-time data tracking for randomization.
  • It can seamlessly integrate with the eClinical landscape, is compliant with all regulatory requirements, and meets international standards.
Interactive Response Technology (IRT) | CliniOps
Validation & UAT | CliniOps

Validation & UAT

  • We perform self-testing of the configuration and setup before releasing it for UAT.
  • Our designers address UAT findings to finally build a data entry system that will be accurate, complete, and user friendly.
  • We provide complete validation documentation (IQ, OQ & PQ) as per regulatory standards.