MANA RBM - September 14, 2020
DENVER, Aug. 27, 2020 /PRNewswire/ -- Today, MANA RBM announced the launch of new remote trial management and oversight capabilities in collaboration with select vendor partners, Bio-Optronics Inc., TransPerfect's Trial Interactive, and Integrated Clinical Systems.
For over a year, MANA RBM identified and evaluated vendor partners focused on delivering a complete remote trial management approach. As study teams faced the sudden pain of COVID-19 upending their clinical operations, MANA RBM assembled a complete remote solution that includes technology for collecting participant data, managing investigator site files, delivering training programs, and analyzing specialized data; all delivered remotely without requiring the traditional onsite visits required by older approaches.
For a single trial, this approach will eliminate 360 onsite monitoring visits—saving time, costs, and environmental impact for the sites and Sponsor. Early feedback from site staff included comments such as "That system ROCKS!", "That was the easiest regulatory I've done yet!", and "I hope in the future all trials are done this way".
"We needed systems extremely easy for the sites to use and that collected data from subjects in near real time. MANA RBM's oversight approach is based on immediate remote review of data from subject visits. Our partners, Alpha Clinical Systems and Bio-Optronics, developed and delivered a fantastic system. We collect eConsent, Patient reported outcomes, clinical data, and CTMS functions, all with the same system," said Penelope Manasco, M.D., CEO of MANA RBM.
"We are delighted to work with MANA RBM and establish an operational, remote trial management solution utilizing our flexible, integrated CCTrialSuite®," states Laku Adedoyin, CTO of Bio-Optronics. "As the trial landscape continues to evolve, we aim to ensure all research organizations are fitted with a trial management/oversight solution that enables high-quality outcomes in a remote or hybrid environment."
"Our team actively collaborated with MANA RBM to design solutions to reduce site burden and to provide real-time insights into study conduct and remote monitoring, by providing an integrated eClinical platform consisting of eSource/EDC/eConsent and ePRO," states Murthy Gandham, President and CEO of Alpha Clinical Systems. "We further extended our platform to enable de-centralized and hybrid trials, with telemedicine and ambulatory care support."
Site Files and Study Team Training
"Electronic Investigator Site Files and Learning Management Systems are key to managing all documents and training for a trial remotely. Transperfect worked with MANA RBM to develop a robust, automated site-specific document management system and Learning Management system which eliminated the need for onsite visits," Dr. Manasco said.
"MANA RBM and Trial Interactive's shared vision is to get global study teams on the path to remote trial management for operational flexibility, enhanced oversight, and complete transparency into documents and data," said Michael Smyth, Division President and Corporate VP, TransPerfect Life Sciences, Trial Interactive. "Our collaboration is ensuring sponsors, sites, and CROs can easily manage site files and training programs, and for the required records to be seamlessly indexed in the eTMF."
"Robust analytics are critical to conducting remote trial oversight. Integrated Clinical Systems' JReview® plays an essential, complementary approach to our analytic oversight strategy. J Review delivers our unique Subject Profile Analyzing Risk (SPARTM) for patient oversight that saves 95% of monitoring time. It also integrates with REACHERTM, MANA RBM's patent pending, automated analytic tool that automatically identifies the Errors that Matter and recognizes systematic errors," Dr. Manasco reported.
"We've really enjoyed working with the MANA RBM team over the past few years, and realize their approach of defining JReview graphic patient profile content (SPAR) greatly increases the ability to pinpoint issues during the clinical data review. In addition, we've seen that the many built-in clinically relevant reports and graphic visualizations in JReview greatly increases the speed they can deploy their concepts for new trials." Eric S Herbel, President, Integrated Clinical Systems, Inc.
MANA RBM salutes our innovative vendors that helped actualize the vision of a complete remote trial management system - one that does not leave the research sites on the sidelines. "Research sites are essential to supporting research subjects/patients and MANA RBM's approach includes them at every step," said Dr. Manasco.
SOURCE MANA RBM
MANA RBM - August 12, 2020
DENVER, Aug. 12, 2020 /PRNewswire/ -- MANA RBM and CUSP announce the randomization of the first subject in ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients, clinicaltrials.gov #NCT04237584].
Enrolment is planned for patients with metastatic prostate cancer which progressed with initial androgen deprivation therapy (mCRPC). Patients will be randomized to either darolutamide or enzalutamide, focusing upon detailed safety and tolerability analyses, in addition to clinical outcome assessments, with subsequent addition of radium-223 dichloride or placebo. This phase 3 trial plans to accrue approximately 500 subjects.
Dr. Neal Shore of Carolina Urologic Research Center, the Principal Investigator for the trial, designed the treatment paradigm in collaboration with Dr. Oliver Sartor, Professor at Tulane University School of Medicine. Dr. Shore stated, "The eventual outcome analytics may potentially enhance treatment options for mCRPC as patients as well as augment our understanding of advanced prostate cancer sequencing strategies. We are honored to have enrolled and randomized the first subject and are very appreciative of our trial site organization's ongoing commitment."
The CUSP Group is a Clinical Research Consortium composed of 24 large tertiary uro-oncology community research practices. As a trial management organization, CUSP supported ESCALATE protocol development, constituted the study network and conducted preliminary protocol education as well as rapid budget and CTA harmonization. As a research advocacy group, CUSP endeavors to bring scientifically interesting and operationally well-crafted trials to its members. These CUSP consortium exclusive studies allow for the early adoption and rapid diffusion of new technologies, medicines, and procedures into the affiliated clinical practices. Additionally, as part of this CUSP advocacy mission, Thomas Paivanas, Executive Director of CUSP, said, "We are excited to be testing a complete digital research ePlatform developed by our colleagues at MANA RBM to conduct overall trial management and remote oversite. These endeavors promise to provide an integrated, potentially paperless system that works well for our research sites, saving them time and enhancing quality."
MANA RBM, the study sponsor, is a clinical trials institute and research laboratory. It is a leader in designing, testing, publishing, and pioneering enhanced methods for remote trial management and quality risk- based monitoring oversight for clinical trials. "For nearly a decade, we have continually enhanced our systems for remote trial management. We are excited to work with Drs. Shore and Sartor in collaboration with the CUSP Clinical Research Consortium to conduct this critical study and to enhance the way sites are able to conduct clinical research," said Penelope Manasco, M.D., CEO of MANA RBM. "We are also excited to announce another unique aspect of this Trial - the launch of REACHERTM. It is the first clinical trial quality management system, based on patent pending software, designed to automatically identify critical, protocol specific errors and systematic errors in near real time across all of the myriad of clinical trial technology systems."
SOURCE MANA RBM
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