Our Risk Based Monitoring solution help the sponsor to monitor the progress of trials through Data Mining and Clinical Data Visualisation
Genpro has developed an intelligent submission framework that will help sponsors to better prepare for their NDA/PMDA submissions.
Genpro brings together an experienced team of statisticians, Statistical programmers and Clinical Data Scientists.Our team of experts drives innovation and foresight to deliver simple solutions to your most complex problems. We drive time to market with cutting-edge software and data management solutions. We work with you as a strategic partner.Our team includes some of the most experienced and innovative professionals in the clinical research segment. We are excited to tell you about the value that we have collectively created. We are even more excited to drive success for you.
Genpro offers an experienced team of clinical data managers and clinical data coordinators who comes with a life science background. They are trained in ICH/GCP as well as CFR PART 11 guidelines. Genpro has extensive experience in various EDC tools and provides EDC setup services to different phases of clinical trials.
We deliver consulting services in the areas of Biostatistics, Statistical programming, FDA interactions and Regulatory interactions. At Genpro we have an experienced and dedicated team of developers with detailed knowledge of all phases across the drug development spectrum.
GenPro offers expert consulting services on complex statistical issues encountered during study design or analysis. We provide guidance in incorporating and analysing the effectiveness of statistical methodologies in clinical trials with a great deal of expertise in adaptive designs and Bayesian analysis.
Genpro provides clinical data visualization dashboards and drill down reports to help sponsors to monitor their clinical and safety data. We can provide sponsors with web based dashboards to monitor their clinical data including tabular and graphical reports from a single database or across multiple databases.
Genpro provides strategic consulting services in regulatory submissions, data submissions and early stage studies.Our expert pool of statisticians, regulatory experts and Submission specialists will help our clients at every stage of the trial. We will support you through the FDA interactions and data monitoring committee support.
Genpro has a pool of medical writers and medical coders with several years of experience across various therapeutic areas. Our consultants are trained on ICH E3 guidelines and work very closely with our US team of statisticians and medical writers.
“Employing Big Data and Operational Analytics on Clinical Data gave us very insightful perspectives about the trial”
“Exposure to trials all the way from paper CRF to state of the art EDC systems makes the group process compliant”
“Deep statistical understanding of trial design and highly competent programmers is what makes this group unique”