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Efficacy/Safety Analysis

Efficacy and safety analysis form the most important part of data analysis pertaining to any clinical trial study. Efficacy analysis involves statistical analysis to determine the effectiveness of the administered medication while safety analysis involves determination of the safety of the medication.

Kreara has extensive experience in carrying out efficacy and safety analysis for studies in various therapeutic areas. As part of the efficacy analysis, the services provided at Kreara are performing the statistical analysis and presenting related outputs. As part of the safety analysis, Kreara’s services include development of tables related to safety data like Adverse Events and Laboratory Data. SAS macros are developed for outputs related to safety analysis thereby ensuring quality and timeliness of the services.

The Statisticians, SAS programmers and quality personnel at Kreara work as a team to ensure that the outputs provided as part of the above analysis meet the client’s standard and timeline requirements.

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