Top 5 tips for managing risks in your Clinical Studies - Pepgra

1. HOW TO MANAGERISKS IN CLINICALSTUDIES TOP 5TIPS An Academic presentationby Dr.NancyAgnes,Head,TechnicalOperations,Pepgra Group: www.pepgra.com Email:pepgrahealthcare@gmail.com

2. Today'sDiscussion OUTLINE In-Brief Introduction Top 5 Tips for Managing Risks in Clinical Studies Conclusion

3. In-Brief Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highestriskareas while preserving patient safety and data reliability inPatient recruitmentfor clinical trials. How can sponsors implement a vigorous process to allow earlier documentation of emerging risks during a trial? Pepgra blog covers five tips for significant risk levels, categorizing risk and maintaining oversight to confirm that risks and responses are correctly identified, documented, tracked, and achieved throughout the patient recruitment companies' life cycle and offerspatientrecruitment clinical trials.

4. Introduction Risk management includes a series of activities or processes undertaken through a clinical trial's life cycle to recognize, evaluate, monitor, switch, prevent, moderate, communicate, and analyze any factor that threatens the test'squality. It pertains to participants' risks and all other steps related to the prosecution, especially the trial data's quality, consistency, andintegrity. Risk management must start at the trial opening so that risk justification can be a part of the protocol and additional essential forms and clinical researchpatient recruitmentprocess.

5. Top 5 Tips for Managing Risks in ClinicalStudies OUTLINING YOUR LEVELS OFRISKS Risk is a natural incidence in any trial at the program, study level, site level and workinglevel. Defining it is the first step to attainingcontrol. At a high level, the full risk of a study can beassessed. For eg, a Phase II oncology study would specify a higher risk that needs a more rigorous monitoring strategy than a low-risk Phase IV observationalwork. Contd...

6. Study risks can also differ based on known, high-performing spots versus new sites with less knowledge of clinical trial recruitment companies' helpfularea. Finally, operational risk can be projected based on real-time patient acceptance data to compare actual presentation to theforecast. EVALUATING AND CATEGORIZING RISK The distinct levels of risk at the study, site and working levels, and overall risk valuation can be produced for a protocol and across aprogram. Contd...

7. The Risk Assessment Categorization Tool, One module of the platform, relates an algorithm to generate an overall category score based on the chance, impact and detectability of the risks, permitting sponsors to make a data-driven decision about the most suitable interventionlevels. CONCENTRATING ON ESSENTIAL AREAS OFRISK After risks are considered, they can also be riddled through Monitoring's user interface to highlight those with the most significant impact on a study, enabling sponsors to redirect resourcesappropriately. With Risk and Issue Management, all study team members can create, view, and manage real-time issues from a single interface using patient recruitmentservices. Contd...

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9. For instance, if the framework recognizes key risks as inordinate underreporting and patient maintenance, the support andCROcan cooperate to guarantee they are checking and controlling these regions for the examinationduration. This cycle empowers early usage of preventive activities and can help limit quality disappointments. OBSERVING AND CONTROLLING RISKS While observing the risks defined and categorized, it's essential to monitor the changes' status throughout a study'slife. Contd...

10. With automatic metrics, the system makes recommendations to escalation, reduction, or maintenance Monitoring at a site using essential risk indicator scoring for clinical trials patientrecruitment. It helps the trial's project team take action and allows sponsors and CROs to prioritize and target particularareas. The automated process also helps manage growth paths and fulfils regulatory guidance surrounding adapted and triggered sitemonitoring. Contd...

11. ESTIMATING THE EFFICIENCY OF RISKMANAGEMENT As risks are identified, categorized and achieved over time, sponsors and their supportive CRO can view the increasing actions taken month over month, assessing their level of success and determining if the activitiesaccomplished helped bring a site back to a lower risk level in clinical studyrecruitment. Ideally, sponsors should see that a more significant proportion of sites are moving into the standard and low-risk categories over time, with an overall decrease in the high-risktypes. This transparency level helps with continuous improvement practices and demonstrates full control and compliance with regulatoryagencies.

12. Conclusion With today's extensive global trials and virtual project teams using several systems acting in separation, sponsors need an effective method to quicken decision making and close the gaps in trialerror. Unifying quality and risk supervision across a single studyor a portfolio of studies support revealing signals before they become general issues that disrupt atrial.

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