Clinical Data Management

services

Clinical Data Management

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.

Data Management Plan (DMP) Development

Data Management Plan (DMP) Development:

  • We develop comprehensive end to end DMP which includes:
        – data entry and data tracking guidelines
        – quality control measures
        – SAE reconciliation guidelines
        – discrepancy management
        – data transfer/extraction
        – database locking guidelines
  • The team works on a robust portfolio and strives to ensure the highest quality.

 


Database Design

Database Design:

  • Our expert database designers works closely with multidiscipline trial team to incorporate and implement protocol requirements and user specifications for database design.
  • Our database development will include FDA compliance, database validation and documentation, version control tracking and documentation, product accountability.

 


Dictionary Coding

Dictionary Coding:

  • Irrespective of the type of dictionary your study needs, our highly adaptable and automated dictionary coding platform will accurately and reproducibly code your medical history, therapy, procedure, and adverse event terms.

 


Import of External Data

Import of External Data:

  • Import, Integration, and cleaning of external data (lab data, ECG, biological assays, Patient Diary, data from remote clinical monitoring devices, etc.) are an integral part of all studies. We design and validate programs to import and format data from third party vendors to ensure the integrity of the data. Our programs use verification checks to guarantee that the data imported from each external vendor is accurate and complete.

 


Other Data Management Services

Other Data Management Services:

  • E-Source data capture and integration training.
  • Development of custom dashboard and report.
  • 24/7 helpdesk support
  • Data quality control audits