Quality Management Services
Quality management is important for a successful clinical trial. It ensures the trial is being done in an ethical manner and, at the same time, meets certain standards put in place. Protheragen offers such quality management services that are optimized for the entire clinical trial so that the best compliance and quality standards are adhered to.
Introduction to Quality Management
Clinical trial quality management alludes to the systematic framework designed to guarantee that the execution of clinical trials satisfies the maximum level of safety, validity, and legislation standards. Its execution includes the establishment of solid systems aimed at measuring and enhance the quality of various clinical research activities. Quality management means ensuring that the organization does not only apply compliance regulations but also enhances excellence culture throughout the stages of the trial such as planning, designing of the protocol, collecting, analyzing, and reporting the data.
The Importance of Quality Management
Scientific Rigor and Validity
When considering the scientific viewpoint, the importance of the clinical trial data is crucial. Quality management targets obtaining data that is correct, dependable as well as valid. This is accomplished through stringent procedures for data collection, entry and validation. For instance, double data entry and validation checks are common practice that lessen the chances of errors and safeguard the data. Quality management facilitates abiding to strict data quality standards, which in turn increases the credibility of the trial outcomes, which are critical in devising new therapies and medical interventions.
Patient Safety
Ensuring the safety of participants in research is an important aspect that has to be taken seriously. Quality management systems have been made to take care of ethics, safety, and health of all the participants. More so, Quality management encompasses the monitoring of participant's safety and the capability of reporting adverse events or safety concerns after they have occurred as well as assuring that the informed consent processes to be obtained at the beginning of the trial are fair and that its' participants understand the advantages and disadvantages of being part of the study.
Our Services
Protheragen provides a full suite of services extending from clinical right management which is embedded with comprehensive quality control and compliance. We ensure a high standard quality and compliance of all aspects of each clinical trial as endorsed with the respective clients' needs.
Quality Assurance
Protheragen operatively monitors compliance with GCP, SOP and other relevant regulations through independent audits, inspections and assessments.
Quality Control
Ensuring quality through data reviews, verification of source documents, CAPA management, and other measures to protect the data and comply with the protocol.
Risk Management
Employ a risk-based approach to identify, assess, and analyze threats that could compromise participant safety and data quality.
Training and Competency Management
Protheragen undertakes diverse training programs in order to make sure that the relevant personnel assigned to the clinical trial are properly qualified and suitable for the task.
Document and Change Management
Protheragen controls and coordinates all clinical trial documents including essential documents creation, revision, approval and distribution and change control.
Vendor Management
Protheragen determines, chooses, and follows up the processes and performance of third party providers to ensure quality and compliance standards are met.
Effective quality management is critical to the success and integrity of investigator initiated trial (IIT) and clinical trials. Protheragen has the capacity to provide drug development lifecycle management services to clients owing to their extensive transformational knowledge within the domain of clinical research. If you are interested in our services, please feel free to contact us.
