SOP & Process Improvement

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Standard operating procedures and Process improvement
 

For Sponsors and Clinical Research sites, producing quality work requires that all participants in the research process work according to unambiguous site specific Standard Operating Procedures (SOPs). In fact, the entire clinical trial process from regulatory submission to the filing of the analytical results should be described by a continuous series of SOPs. Unfortunately, this step is too often overlooked, incomplete, or given to individuals who are not equipped for the role.

ClinPharm Network, Inc. believes that “a Standard Operating Procedure (SOP) must be in place—whenever and wherever—clinical research is conducted to ensure that operations are carried out correctly and always in the same manner in order to guarantee the best results.” SOPs are the key to ensuring that your team can deliver accurate results with thorough supporting documentation.

ClinPharm Network, Inc. has extensive experience assisting Sponsors and clinical trial facilities in the creation of site and/or trial specific SOPs. Moreover, ClinPharm Network, Inc. has expertise in the review and revision of existing SOPs for in-process trials in circumstances where results are not meeting expectations.

The ClinPharm Network, Inc. team has written and revised hundreds of SOPs covering all departments in essentially every type of clinical research facility. ClinPharm Network, Inc. has developed SOPs of all types including:

  • Fundamental Clinical Practice SOPs—including instructions on how to create SOPs for any process or procedure
  • Training and Training Documentation SOPs
  • Patient/Participant Recruiting SOPs
  • Drug Accountability SOPs
  • Safety precaution SOPs
  • SOPs for operating instruments, equipment and other apparatus
  • Sample Handling SOPs
  • Participant/Patient Admission and Screening SOPs
  • SOPs for obtaining and sending of biological samples SOPs
  • Quality Assurance SOPs
  • Archival SOPs—track, manage and create compliant archival data

Contact ClinPharm Network, Inc. today for assistance with existing SOPs or to develop new comprehensive Standard Operating Procedures.

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