Leading regulator, quality and clinical consultants bring more than 25 years of experience to health products offering guidance, the peace of mind to move forward with confidence and success with the new risk-based quality management research methodologies.
Pharmaceutical, biotech, and medical device industries experiencing unprecedented economic upheaval can no longer justify practices that deliver little value at exorbitant cost. Rather than continuing to spend time, energy, and money focusing on minutiae; those engaged in clinical trial conduct must re-focus their energies on the aspects of the clinical trial that matter most, such as protocol compliance, subject safety, data timeliness, and data integrity.
While implementing a Risk Based Monitoring (RBM) approach, three key aspects need to be taken into consideration regarding change management related to process, people, and technology needs. In these three key aspects, the process is very critical as it broadly influences the other two aspects. For RBM implementation, the monitoring plan is the heart of the process as it outlines how RBM is being implemented and how effectively monitoring of a study is being done with this new initiative. Therefore, developing an effective, study specific risk based monitoring plan is very crucial for RBM implementation.
Our team advice and supports health companies to effectively address these concerns while saving both time and money.