MANA RBM Salutes Vendor Partners Delivering Remote Trial Management and Oversight Tools: New Solutions for Adapting to the Operational Impact of COVID-19


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".  

Participant Data
"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."

Data Analysis
"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.  

Media Contact:
Penelope Manasco
919-556-9456
246229@email4pr.com

SOURCE MANA RBM

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Potential Enhancement of Prostate Cancer Treatment Options: First Patient Randomized in Phase III Trial


MANA RBM - August 12, 2020

https://www.prnewswire.com/news-releases/potential-enhancement-of-prostate-cancer-treatment-options-first-patient-randomized-in-phase-iii-trial-301110702.html

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."

Contact: Penelope Manasco, M.D., CEO at 245139@email4pr.com or 919-556-9456, http://www.manarbm.com

SOURCE MANA RBM

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COVID-19 ELIMINATING ONSITE MONITORING VISITS IN CLINICAL STUDIES

MANA RBM HAS THE IMMEDIATE REMOTE RISKED BASED MONITORING SOLUTION

By Penny Manasco - March 9, 2020

Our network of clinical researchers reported that research sites are eliminating onsite monitoring visits. If onsite monitoring visits are your main oversight approach, the solution to this problem is available now. 

MANA RBM provides remote risk-based monitoring (RBM) customized to your protocol.  We deliver our solution, customized to the areas of greatest concern, specific to your study.  Subject review can begin within days.

We recently published an example of this successful approach, adding remote Risk Based Monitoring to trials being conducted with traditional SDV.  Within days, we started remote subject review.  Within 2 months, we identified critical errors that SDV did not find. Here is the link to the head to head comparison:  http://www.appliedclinicaltrialsonline.com/comparing-risk-based-monitoring-and-remote-trial-management-vs-sdv

To protect your subjects, protect your study, and protect your asset, contact us immediately to get started.  Contact Penelope Manasco, M.D  at pmanasco@manarbm.com or 919-556-9456.
 
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The Key to RBM and my New Year's/Decade's Resolution: Ask the Right Question

A conversation with Physician Scientist-Mary Flack M.D.

By Penny Manasco - January 6, 2020

Eight years ago, I had my first real experience working with a Sponsor that exemplified the principles of Risk Based Quality Oversight in her study implementation expectations. That person was Dr. Mary Flack, an NIH-trained physician-scientist and VP of Clinical Research, at NanoBio.  

Dr. Flack had had enough of high priced CROs that performed SDV and missed critical systematic errors (i.e., incomplete dosing at sites and one site that performed its primary efficacy endpoint analysis incorrectly, resulting in that site (a high enrolling site) being excluded from the primary endpoint analysis).  She needed a different approach to determine whether her investigational product worked or not.

Ask the Right Questions! Dr.  Flack was very clear about her High-Risk areas—activities that, if not performed correctly, would sink her trial or give equivocal results—requiring additional multi-million-dollar trials.

The critical questions she asked and the answers MANA RBM provided were as follows:
  1. Q: How can I know if an error occurs as soon as it happens, not months later?  
                   A: Use eSource to review the data in near real time. 
                       Use analytic tools to rapidly identify when an error occurs.  
 
  1. Q: How can I know when a site rater is not following the natural history of the disease in their rating scales in time to effect a change?
A: Change the way data  is reviewed (no need for SDV due to  eSource) so evaluation focuses on the critical errors that must be identified.  The methods to do so are as follows:
  • Ensure all raters were trained.  
  • Review rating scales for each subject AT LEAST weekly to identify errors as they occurred.  This included checking the pattern of data errors, not just whether data were entered. 
  • Identify where there were systematic differences in performance by investigators (e.g., differences in rating of spontaneous resolution of symptoms across investigators at each site).
  1. Q: How can I know when a subject is not getting the recommended dose of the study medication as soon as it occurs?
A: Add more training, data collection, and oversight around study drug administration and dosing.  Rapidly identify errors and correct those errors precluding errors from becoming systematic .  

Dr. Flack clearly enunciated the critical issues needed for successful implementation.  MANA RBM developed an oversight approach that met her needs. The results, including a 50% drop in deviations from previous trials run by traditional CROs, exceeded her expectations.

Now fast forward nearly a decade.  I recently asked her about that trial and what she saw as the future of Risk-Based Monitoring.

“I think we have to start asking the right questions to drive effective clinical trial oversight. I trained as a scientist and while at the NIH, and afterwards, I ask the questions a scientist would want to know. You could call it Science Driven Oversight or SDO, since we have to have an acronym.” 

She further expounded on her thoughts.  “I think much of our challenges with clinical trial oversight stem from the questions we ask. Just as we did nearly a decade ago, I want to know what activities in a trial will result in my ability to successfully complete the protocol as designed.  I want to know what errors occur that can result in censoring subjects, incomplete understanding of whether the subject received the correct dose, and all activities related to the primary endpoints—not just were the values collected, but did they follow the required processes as defined in the protocol.  And I want to know if the errors we see are systematic—a one off error is one thing, but a systematic error that is not identified indicates that we didn’t ask the right question.”

Science Driven Oversight, as Dr. Flack described it, is asking the questions that will affect the outcome/analysis of the trial and subject safety first and foremost.  “You can see that if your question is: “Were all pages SDV’ed or reviewed and  were all queries closed” will result in a very different outcome for oversight than asking “Were the processes for collecting the primary endpoint followed and how do you know? or Were there systematic errors identified at any site that can affect our ability to determine the safety of our investigational products and how do you know?”

Finally, Dr. Flack opined on SDO’s orthogonal view of clinical trial oversight, “When we focus our questions and oversight on the most important areas:  Did X, affecting primary efficacy endpoint, occur?, or Did Y, affecting subject safety, occur?, or did Z occur multiple times?, we can be sure to find the high impact, low frequency errors and systematic errors that affect trial success.”

Using a scientific construct to determine the critical questions we ask for clinical trial oversight is really what the FDA envisions as Risk Based Monitoring.  We ask questions to determine whether errors occurred in the  areas of highest risk for successful trial integrity.  

So, for the new decade, I adopt and encourage everyone working in clinical research to adopt Dr. Flack’s mantra of Science Driven Oversight.  I will think like a scientist, ask the questions a scientist would ask, and analyze study operations with the same rigor used in discovering innovative new medicines.    
 
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The Risks of KRI in RBM: A Response to “A Roadmap for Implementing Risk-Based Monitoring and Quality Management"


By Penny Manasco - June 11, 2019

There are a myriad of articles on RBM implementation. Some authors have us jumping immediately into tool selection before we have even determined WHAT we need to measure. It is essential that we identify Errors that Matter for each protocol and how we will identify whether systematic errors occur. Hopefully this paper will encourage you to step back and define the important errors that need to be monitored. Only then can you determine whether the tool you choose will meet your needs. I'm also encouraging all companies to systematically evaluate different RBM approaches, just as we evaluate different therapies--moving toward Evidence-Based Clinical Research and Quality Oversight.

http://www.appliedclinicaltrialsonline.com/risks-kri-rbm-response-roadmap-implementing-risk-based-monitoring-and-quality-management
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