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Clinical Data Management

Kreara provides a complete continuum of data management solutions to pharmaceutical, biotechnology and medical device industries worldwide. The data management group at Kreara develops a comprehensive data management plan detailing the requirements and actions, based on client input. The data management team undergoes brain storming discussions within the team and with the client to clarify the project requirements.

The data management team at Kreara reflects a blend of internal efficiency, flexibility and experience resulting in a customized service that demonstrates commitment to meeting the timelines and project goals set by the clients. Further, Kreara data management group works to meet high-level global standards.

A set of standard SOPs related to data management ensure that the data management tasks are performed in a consistent manner throughout the company.

Services provided by Kreara under the Clinical Data Management include:

  • Preparation of the Data Management Plan
  • Development and set up of the e-Randomization application
  • Acting as the randomization center
  • Maintenance of the blind for the study
  • CRF design and development
  • Preparation and set up of the e-CRF application
  • Preparation of the Data Definition Table
  • Design and set up of the Database tailored to CRF specification
  • CRF scanning and Data Entry using a Data Entry application with built in validation checks
  • Data Verification using single or double data entry methods
  • Data Validation
  • Execution of the Blind Review
  • Handling of external data like laboratory ranges and pharmacokinetic data
  • MedDRA coding for Adverse Events
  • Coding for Concomitant Medication
  • Serious Adverse Event Reconciliation against client safety databases
  • Raw Data Listings and tables available in formats including Excel and SAS®
  • Data Exports into several formats, including SAS®, SPSS and Oracle®
  • Migration of data into CDISC standards

Testimonials

  • "Kreara's agile programming methodology was a welcome change from the previous outsourcing experience that we have had. With a team of 10 people which comprised of a business analyst, a scrum master and 6 programmers and 2 QA engineers, we were able to quickly ramp..." a US based Fortune 500 company

  • "SAS Programmers from Kreara has an exceptional experience across various therapeutic areas. They were also able to do a quick turnaround in the Phase IIB trial by providing the necessary TFLs within one week of database lock" Director Biostatistics of a European CRO

  • "It usually takes about three months to convert a legacy database into the CDISC format. Kreara programmers were able to do it in less than a month with the sound domain knowledge that they had in oncology and CDISC specifications" Director Data Management from a European Pharmaceutical Major

  • "While medical coding remains one of the most costly affairs in Europe, Kreara was able to successfully use the medDRA and WHODD to perform the medication coding at costs that were extremely competitive" Director Data Management of an East European CRO

quick contact

Quick contact info

  • Kreara Solutions Private Ltd.
  • T-4, 7th Floor, Thejaswini Building,
  • Technopark Campus,
  • Thiruvananthapuram (Dist),
  • Kerala State, India.
  • Pin: 695 581
  • Phone: (00)91 - 471 - 2527640
  • Phone: (00)91 - 471 - 3043049
  • Email:info@kreara.com
  • www.kreara.com
  • www.technopark.org