Advarra

MAY 25, 2022

That’s why direct communication and integration between key technology systems like email, electronic institutional review board (eIRB) systems, clinical trial management systems (CTMS), and other eRegulatory (eReg) platforms all contribute to a more efficient and compliant trial. Email Integration. eReg-to-eReg Integration.

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Advarra

JUNE 16, 2022

Securing oversight committee approvals (IRB, IBC, SRC, RSC, COI, feasibility) . Sponsors and Sites : Submit Materials to Your IRB for Approval . Partnering with an experienced IRB increases opportunities to streamline the activation process. Need additional guidance on review requirements? . FDA-USA, BfArM-Germany)

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ACRP blog

JANUARY 18, 2023

“Questions come in all the time, on topics as diverse as how to handle a conflict at a particular site, how to find an appropriate site in a specific geography, how to handle adverse events or institutional review board (IRB) reporting, or the loss of original clinical trial records. View complete schedule. . Author: Jill Dawson.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 17, 2021

Regular communication (either personally or through integrated CTMS solutions ) can improve trust and help in understanding the effects of the clinical trial better. The role of the Institutional Review Board (IRB) in ensuring patient safety. IRB is an independent board of physicians and other appropriate parties.

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Clinical Trials Clinical Trials Trials Clinical Research 71

Advarra

APRIL 23, 2024

Are we ready for increasing new single IRB (sIRB) mandates? In addition, if a recent change has resulted in accumulating reviews or “to dos,” interim staff can help your HRPP clear any backlogs. Should we pursue accreditation?” Maybe your organization has a vision for modernizing the HRPP.

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Trialfacts

OCTOBER 23, 2023

That being said, the need for a safe and effective solution is more critical than ever. This intervention combines cognitive behavioral therapy (CBT) and mindfulness techniques, offering a solution without the potential troublesome side effects associated with medications. You’re not alone! Interested?

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Trialfacts

NOVEMBER 12, 2023

47257 Fremont Blvd, Fremont, CA 94538, United States Lead Researcher: Dr. Grace Gardner IRB Committee: This study has been reviewed and approved by the WCG Institutional Review Board About the Study Did you know that approximately 1 in 7 people living in the United States have hearing loss? Location: Sonova USA, Inc.,

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Trialfacts

MAY 18, 2023

Lead Researcher: Deepak Kumar, PT, PhD IRB: This study has been reviewed and approved by the Boston University Institutional Review Board About the Study Do you experience chronic knee pain? Join this study today and become part of the solution! You’re not alone. Why Participate?

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Clinical Trial Podcast

JULY 18, 2020

Sites are responsible for site-specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. Technology solutions. Close-out fees.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Trialfacts

OCTOBER 5, 2023

IRB: This study has been reviewed and approved by the UT Austin Institutional Review Board About the Study Alcohol use disorder is significantly more prevalent in individuals with bipolar disorder, a connection that appears to be influenced by genetics and familial factors. Take action now—be part of the solution!

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Research Genetics 52

Trialfacts

OCTOBER 3, 2022

IRB: This study has been reviewed by WCG IRB. Sonova, headquartered in Stäfa, Switzerland, is a leading provider of innovative hearing care solutions. About the Research Centre: Location. Research Centre: Sonova Canada. Location: Sonova Innovation Centre Toronto, 3105 Glen Erin Drive #2, Mississauga ON L5L 1J3, Canada.

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Cloudbyz

NOVEMBER 12, 2021

There are also a number of solutions; some of them new and burgeoning, while others are tried and tested. The recruitment plan along with the recruitment materials based on the plan are then presented to the relevant Institutional Review Board (IRB), which must then review the submissions and approve or reject them.

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Advarra

JULY 19, 2022

For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records. while the IND is in review? Keep any records showing how the sponsor oversees vendor activities.

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Packaging Packaging Drugs Containment 52

Advarra

JULY 19, 2022

and guidance documents suggest the agencies clearly prefer a non-English speaking participant review a translated version of the complete study consent. For those unexpected situations, some institutions and institutional review boards (IRBs) maintain an approved short form consent translated into multiple languages.

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Research Regulation Trials Compliance 52

Trialfacts

JANUARY 11, 2023

The company serves consumers in more than 100 countries around the world, providing a range of hearing care solutions, including personal audio devices, wireless communication systems, audiological care services, hearing aids, and cochlear implants. Location: Biometrics lab within the Sonova USA Inc.

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Advarra

JANUARY 10, 2023

As the clinical research industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. In the worst cases, they may have to report the mistake to their institutional review board (IRB) or receive a warning letter or notice for an audit finding.

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Clinical Trials Clinical Trials Clinical Research Research 52

ACRP blog

DECEMBER 21, 2022

An electronic trial master file (eTMF) is a technology solution designed to organize, collect, store, track, and archive required and essential study documents. Additional Resource : 12 Items Auditors Look for When Reviewing an Investigator Site File. What is an Electronic Master File (eTMF)? . What Documents are in an eISF?

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WCG Clinical

JANUARY 4, 2024

But while digital devices, mobile applications, and online communication methods are useful tools, they are not complete solutions. Likewise, sites can optimize and grow their research businesses by harnessing solutions that improve site capacity, reduce start-up delays, and lessen their administrative burden.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Advarra

JUNE 14, 2022

Regardless of the collection method, the questions and any accompanying script must first be reviewed by the IRB to ensure the materials presented are not beyond the scope of the inclusion/exclusion criteria. In this critical time, sites review the inclusion and exclusion criteria to determine a potential patient pool for the study.

Trials 52

Trials Clinical Trials Clinical Trials Research 52

Advarra

JULY 18, 2022

An electronic trial master file (eTMF) is a technology solution designed to organize, collect, store, track, and archive required and essential study documents. Additional Resource : 12 Items Auditors Look for When Reviewing an Investigator Site File. What is an Electronic Master File (eTMF)? . What Documents are in an eISF?

Research 52

Research Clinical Trials Clinical Trials Compliance 52

WCG Clinical

JULY 25, 2023

Before digging into the changes, let’s review the platform itself. My Patient offers a comprehensive solution to effectively track participant progress from initial prescreen to final disposition, whether that is enrollment or disqualification. Changes include expanded data fields, new functionality, and an improved overall interface.

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Clinical Trial Podcast

FEBRUARY 23, 2021

During a periodic data review meeting, the project manager finds out that the site has a significant number of protocol deviations. Once the study-specific ICF template is sent to the sites, the site’s personnel review and edit the ICF to meet their site-specific IRB/ Ethics Committee requirements.

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WCG Clinical

JULY 17, 2023

Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report , gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.

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Clinical Trials Clinical Trials Trials Research 52

Advarra

OCTOBER 4, 2022

The right tools can ensure mutual success, such as additional training resources, a financial feasibility analysis, and a centralized institutional review board (IRB). It’s important to remember there is a time frame between selecting and activating a site, during which these tools can be implemented. How Advarra can help.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Camargo

JUNE 4, 2021

Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (Revision 1).

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Cloudbyz

JUNE 13, 2023

Costs associated with obtaining necessary approvals, Institutional Review Board (IRB) fees, and ensuring adherence to Good Clinical Practice (GCP) guidelines should be accounted for. Budget Approval and Oversight: Clinical trial budgets undergo review and approval processes by sponsors, research organizations, and regulatory bodies.

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Clinical Trials Clinical Trials Trials Marketing 69

Cloudbyz

JUNE 11, 2023

Decentralized Trials Platforms Decentralized trial platforms are software solutions that enable the management of DCTs. Ethics Committee Approval: As with traditional trials, DCTs must obtain approval from the relevant ethics committees or institutional review boards (IRBs).

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Clinical Trials Clinical Trials Trials Compliance 74

XTalks

DECEMBER 4, 2020

In addition, nephrology-related devices — including dialysis solutions, renal replacement therapies and interventional devices — also afford many opportunities for innovation to improve upon patient outcomes including quality of life. Operational Perspective of CKD Trials. Optimizing Patient Enrollment and Retention. 1] Cockcroft, D.W.

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