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SOP

Standard Operating Procedures, commonly referred to as SOPs, are documents which describe the standard processes that the company should adopt while carrying out company and project related activities. At Kreara, around 50 SOPs have been developed under the following sections

  • General activities
  • Project management
  • Data management
  • Statistics
  • SAS

The SOPs are developed based on the standard template which have sections describing the document (including author, reviewer and approver names), the revision chronology, effective date and the scheduled review date. At Kreara, the SOPs are made self explanatory by describing the process in detail with the help of flowcharts.

An SOP Review Board (SRB) is appointed comprising of the Director Operations, Project Manager and the Quality Assurance Manager, which is responsible for the development and maintenance of the SOPs. The SOPs are reviewed and updated on a periodic basis to ensure that the documents are not obsolete and any change in process has been documented. If at any point it is felt that a new SOP needs to be developed, the request is placed before the SOP Review Board (SRB). The SRB meets and decides the requirement of the new SOP and if approved, supervises the development and the implementation of the SOP. SOP Checklists are developed against each SOP to assist the Quality Assurance Manager to check for process adherence for the various project related and general activities.

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