Rethinking Clinical Trials

AUGUST 30, 2023

We are excited to welcome I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) to our portfolio of innovative Demonstration Projects. This project is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute on Aging (NIA).

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Cloudbyz

APRIL 30, 2023

Cloudbyz’s Unified Clinical Trial Management Solution, built on the Salesforce platform, offers a comprehensive, customizable, and secure platform for streamlining clinical trial operations. Cloudbyz solutions include Study Start-Up, CTMS , CTBM , eTMF , RTSM , EDC , eCOA , eConsent , e PRO , Safety & Pharmacovigilance.

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Pharmaceutical Technology

OCTOBER 26, 2022

Unplanned protocol deviations, which add time and cost to a study, are also contributors to complexity. According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial.

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Rethinking Clinical Trials

OCTOBER 11, 2023

Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. In implementation studies, how can you blind outcome assessor? Is independent adjudication a possible solution?

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Cloudbyz

MARCH 17, 2024

Salesforce ‘s Life Sciences Cloud: Transforming Research and Development Salesforce, a leader in cloud-based customer relationship management (CRM) solutions, has unveiled its dedicated Life Sciences Cloud, tailored specifically to meet the complex needs of the industry.

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WCG Clinical

MAY 9, 2023

This process decreases the number of required protocol amendments and highlights key risks and mitigations during the planning phase of the trial. Making the investment in a protocol optimization solution like this is key to conducting faster, higher-quality clinical trials.” Princeton, N.J. –

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Cloudbyz

FEBRUARY 21, 2023

The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, monitoring reports and others. The inspection may include a review of the TMF documentation, as well as interviews with study staff and site visits to verify the trial’s conduct.

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WCG Clinical

JUNE 28, 2023

Princeton, NJ, June 28, 2023 — WCG, one of the world’s leading providers of solutions that measurably improve the quality, efficiency, and safety of clinical research, recently announced a partnership with Mint Medical to leverage its mint Lesion™ radiology platform for oncology trials.

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ACRP blog

MARCH 19, 2024

Maintaining patient engagement and minimizing dropout rates in clinical trials is a persistent hurdle, with dropout rates soaring up to 30% in some studies. However, purpose-driven eClinical solutions like ENGAGE!, The Solution: ENGAGE! ENGAGE! Compliance: Safeguards adherence to regulatory requirements and study protocols.

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Clinical Trials Clinical Trials Compliance Trials 59

Cloudbyz

APRIL 17, 2024

Clinical trials typically require a large number of patients to participate, but DCTs often require patients to use technology to complete study procedures remotely. Additionally, DCTs may not be suitable for some disease areas or study designs, which can limit their usefulness in clinical research.

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Clinical Trials Clinical Trials Trials Compliance 75

Pharmaceutical Technology

JULY 8, 2022

Xenetic Biosciences and Catalent Pharma Solutions have signed an agreement for the cGMP manufacturing of the Xenetic’s recombinant protein, Human DNase I. Currently, Catalent is planning to carry out the first-in-human study to assess DNase in combination with immune checkpoint inhibitors or chemotherapy.

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Clinical Trial Podcast

APRIL 23, 2023

In this episode, we’re going to talk about Postmarket Surveillance Studies. In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.

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VirTrial

OCTOBER 6, 2023

Digital health technology (DHT) solutions are now widely adopted and applied in today’s clinical trials. At Signant, to ensure that our solutions are fit-for-purpose in terms of patient and site usability, we routinely engage with sponsors, sites, and potential or current trial participants in qualitative research.

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Pharmaceutical Technology

APRIL 3, 2023

The development pipeline of such therapies has been growing strongly and more and more are reaching major milestones,” said René Fáber, member of the executive board and head of the bioprocess solutions division of Sartorius, in a statement.

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pharmaphorum

OCTOBER 18, 2022

Now that the COVID-19 pandemic has provided the industry with a solid foundation of experience with decentralised trials, it is appropriate to reflect and ask whether DCT studies are truly helping to address long-standing issues in research and development for sponsors, study teams and, most importantly, patients.

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pharmaphorum

DECEMBER 2, 2022

These problems are compounded with site-level concerns about protocol complexity, staffing shortages, low patient interest, and budgetary constraints — leaving sponsors to question how to plan trials that deliver against timeline commitments to support launch goals. Country expansion to support enrolment. Integration of data is key.

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Camargo

JUNE 15, 2021

We identified the 505(b)(2) pathway as the best pathway for product approval and prepared and led interactions with CDER and the Office of Orphan Products Development to help the sponsor gain clarity on what the development plan should look like.

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ACRP blog

MARCH 7, 2024

The Mixed Bag of Technology Encountered in a Study Sponsors and CROs encounter a diverse array of technological readiness among sites participating in their studies. These platforms often are siloed and require sponsors to create bespoke monitoring plans and startup plans for every site.

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Clinical Trials Clinical Trials Clinical Research Trials 59

Worldwide Clinical Trials

MARCH 1, 2023

Through the 1990s, sponsors required a more sophisticated offering from CROs who were required to master fundamental study operations and processes, offering scalability to sponsors’ operations departments. They also think beyond the single study being discussed to anticipate future needs, supporting a matrix of engagements.

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Trialfacts

MARCH 18, 2024

Contents About the Study Why Participate? A new research study might offer hope. This study aims to explore a potential breakthrough treatment called Retatrutide. Participants will receive lifestyle counselling by a dietitian throughout the study. Your Rights Who Can Participate? Interested? Who Can Participate?

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Cloudbyz

APRIL 9, 2024

Cloudbyz Unified Clinical Trial Management (CTMS) is a comprehensive, integrated solution to streamline clinical trial operations. Built on the Salesforce cloud platform, our CTMS provides real-time visibility and analytics across study planning, budgeting, start-up, study management, and close-out.

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Rethinking Clinical Trials

JULY 14, 2022

Turnover of IT staff at participating sites and changes in site data agencies during the study period. Updates to the EHR that affect study algorithms and other issues with algorithms not identifying data as expected. Overcoming technical barriers with practice workflows and integrating with IT systems.

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Trialfacts

DECEMBER 13, 2023

Contents About the Study Why Participate? A new research study might offer hope. This study aims to explore a potential breakthrough treatment called Retatrutide. Participants will receive lifestyle counselling by a dietician throughout the study. Your Rights Who Can Participate? Interested? Who Can Participate?

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Insulin Research Allergies Production 52

VirTrial

DECEMBER 4, 2023

However, a common challenge is that these systems are often one of the last to be considered in eClinical systems implementation for any particular study. RTSM per-study can also consider what may change in the protocol, and build in scale to the study to reduce the number of study enhancements required.

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Cloudbyz

APRIL 28, 2022

General CTMS features include complete management & maintenance for the functions of performance, planning, and reporting. . A unified CTMS is aimed at keeping track of every relevant part of your trials and involves integrating a long list of functionalities into your CTMS solution. Why Unified CTMS Solutions Matter.

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Rethinking Clinical Trials

AUGUST 7, 2023

While the Core is still in its early days, the cochairs have plans for how to best serve the NIH Collaboratory. “Early and ongoing engagement of policymakers who are in the position to make policy changes or requirements based on study findings can sometimes overcome health systems barriers,” she said. ” Check said.

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Cloudbyz

APRIL 8, 2024

This can lead to earlier study completion and faster access to new treatments for patients in need. This involves identifying potential risks to data quality and patient safety, such as critical data points, investigational sites, and study procedures. Risk Assessment Not necessarily based on a comprehensive risk assessment plan.

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Clinical Trials Clinical Trials Trials Development 79

WCG Clinical

JANUARY 12, 2024

Thus, an absence of process or lack of experience in one area can significantly affect others, leading to a cascade of problems that undermine recruitment and retention plans. Study team capacity: Multitasking is a myth Effective recruitment, screening, and retention require a consistent and focused approach.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

APRIL 16, 2021

Cloudbyz was approached by a US-based global Fortune 500, a wholesale drug distribution company with a business requirement for end-to-end study management. Solutions Delivered by Cloudbyz. Our approach was strategic and we planned to move in a systematic manner. Curious to know who we really served? Schedule a call.

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Clinical Trials Clinical Trials Trials Life Science 52

XTalks

JANUARY 18, 2024

Peter Maag, PhD, CEO of Kyverna Therapeutics Kyverna Therapeutics is a clinical-stage cell therapy company dedicated to bringing innovative solutions in treating autoimmune diseases. Having that patient experience in mind drives us to bring a novel solution to the clinic. We are doing that through our clinical trial programs.

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Clinical Trials Clinical Trials Trials Life Science 124

pharmaphorum

NOVEMBER 2, 2022

Treating pain has always been complicated because often the most effective solutions come with their own risks. Though it provided a solution, opium also brought with it physical and psychological dependence. The potential for a digital solution. DTx in action.

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Cloudbyz

MARCH 13, 2023

Below are some best practices for clinical trial data management: Develop a Data Management Plan: A Data Management Plan (DMP) outlines the procedures and processes for data collection, storage, analysis, and reporting. Data should be de-identified when possible to protect the confidentiality of the study participants.

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Clinical Trials Clinical Trials Trials Compliance 52

Trialfacts

NOVEMBER 12, 2023

Contents About the Study Why Participate? More Study Details About the Research Center: Location Research Center: Sonova USA, Inc. That’s why this study is testing investigational hearing devices, to find ways for improvement. The information gained in this study may improve hearing aid technology for future users.

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XTalks

JUNE 14, 2023

Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 Vevye is the first and sole cyclosporine solution specifically prescribed for addressing the signs and symptoms of dry eye disease with efficacy validated after four weeks of treatment.

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Camargo

NOVEMBER 20, 2020

So you’ve determined that you need to perform juvenile animal toxicity studies as part of your nonclinical program. The next step is understanding why these studies are required and how they should be designed. Why Are Juvenile Nonclinical Studies Needed? When Are Juvenile Nonclinical Studies Needed?

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Pharmaceutical Technology

AUGUST 10, 2022

According to Jayna Blake, at Baxter BioPharma Solutions (BPS), the need for demonstrable performance and expertise from an established CMO should be at the top of any sponsor’s list of requirements. The CMO should also include the timeline that they can plan for and achieve. Proven results??. Customized support?.

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XTalks

JUNE 3, 2022

A new 3D heart modeling solution by inHEART received FDA 510(k) clearance. The modeling solution allows for 3D visualization and analysis of the heart for pre-procedural planning and intraprocedural use. “We have been using the inHEART solution in clinical research for several years. Photo courtesy of inHEART.

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