Standard Operating Procedure (SOP) advisory services are designed to ensure that the clinical trials adhere to the recommended ethical, regulatory, and scientific benchmarks by providing expert guidelines in developing and implementing SOPs and other GxP-related processes.
What is GCP?
Good Clinical Practice (GCP) is an internationally recognised and established ethical and scientific quality standards that are focused on designing, conducting, recording, and reporting clinical trials involving human subjects.
It ensures that clinical trials data are credible and that the rights, safety, and well-being of trials subjects are protected.
What is GLP?
GLP stands for Good Laboratory Practice which are a set of guidelines that ensure the quality and reliability of non-clinical laboratory studies, focusing on the safety of chemicals for humans, animals, and the environment.
What is GVP?
GVP stands for Good Pharmacovigilance Practices which are a set of guidelines and standards to ensure the safety and efficacy of pharmaceutical products throughout their lifecycle, focusing on identifying, assessing, preventing, and mitigating risks associated with pharmaceutical products.
What is Computer System Compliance Practice?
CSC Practices ensure the integrity of essential documents for clinical trials and the security of the network and applications used in clinical trials. If these systems are not managed properly, they can pose a significant regulatory risk to critical clinical trials data.
What are SOPs?
Standard Operating Procedures (SOPs) are detailed guidelines that ensure consistency and uniformity in the performance of specific functions within a process such as a clinical trials.
They are crucial for maintaining the quality and compliance throughout the clinical trial lifecycle.
What do SOP Advisory Services Offer?
SOP Development and Review
These services help organizations develop, review, and update GxP-related SOPs to ensure they meet regulatory benchmarks and requirements as well as the industry best practices.
Training
SOPs define and detail the training process on GxP principles to ensure that all personnel involved in clinical trials are adequately trained and understand their responsibilities. Our standard training sessions include the latest regulatory updates, therapeutic area trainings, protocol specific trainings, electronic data capture, quality assurance, site evaluation, monitoring visits, CRF review, investigator meetings, and much more.
Quality Assurance and Control
GxP SOP advisory services ensure the implementation and maintenance of quality assurance and quality control systems, ensuring that trials are conducted and data is generated, documented, and reported in compliance with the protocols, GCP and other applicable regulations.
Auditing and Compliance
SOPs can enable efficient and well-defined GCP audits and inspections, helping organizations prepare for and address regulatory inspections.
Document Management
SOPs define the process of managing and storing clinical trial-related documents, ensuring that they are accurate, complete, and readily accessible.
Consulting
SOPs provide expert guidance on GxP principles and practices, helping organizations make informed decisions about their clinical trial programs. We also a service provider for developing SOPs at investigator sites such as hospitals, covering all spheres of implementation of clinical trials.
