WCG Clinical

OCTOBER 6, 2023

Media outreach is a great tool to connect large groups of potential participants to actively enroll in clinical research studies. Just as important, those strategies must always align to study timelines. Who do we want to bring into the study? Where are potential participants most likely to learn about the study?

Clinical Research 64

Clinical Research Trials Clinical Trials Clinical Trials 64

ACRP blog

JUNE 26, 2023

If you, for example, represent a study sponsor, CRO, or technology company whose leaders are interested in networking with more sites, then you should consider submitting an abstract for the ACRP 2024 meeting,” says Cascade, who is also the 2023 Vice Chair of the Association Board of Trustees for ACRP and will be its Chair in 2024. “If

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

JUNE 26, 2023

If you, for example, represent a study sponsor, CRO, or technology company whose leaders are interested in networking with more sites, then you should consider submitting an abstract for the ACRP 2024 meeting,” says Cascade, who is also the 2023 Vice Chair of the Association Board of Trustees for ACRP and will be its Chair in 2024. “If

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Camargo

JANUARY 19, 2021

Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. Pre-Filing Requirements. Pre-Filing Requirements. Pediatric Plan.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

WCG Clinical

APRIL 3, 2023

We all agree on that, but how often is that participant’s perspective considered throughout study planning? It can get lost in the complexity and activity of study startup. Sites and sponsors must begin with one question: What makes sense for the participant? Where is the study taking place?Is Monetary reward?

Dermatology 52

Dermatology Trials Development Clinical Trials 52

Advarra

JUNE 9, 2022

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. Ways to accomplish this include engaging home health groups to come to the participant’s home to collect or administer study tasks, or bringing interventions into the community by setting up a common place for interventions (e.g.,

Clinical Trials 52

Clinical Trials Clinical Trials Trials Trial Funding 52

Advarra

JUNE 26, 2023

For sponsors and their sites, adhering to U.S. This blog provides key insights and guidance for sponsors and sites as they work to mitigate risks and ensure compliance for a successful FDA inspection. Sponsors and sites can significantly impact an FDA inspection’s outcome by following the best practices listed above.

Compliance 52

Compliance Regulation Marketing Production 52

Clinical Trial Podcast

JULY 18, 2020

Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. Clinical sites spend physician and site coordinator time to screen for potential patients. Speak with a few clinical sites to understand how many patients they would have to see in order to find one qualified patient. Site costs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

ACRP blog

NOVEMBER 16, 2023

You may be happily using ChatGPT to produce meeting minutes or literature reviews, and your children may be secretly using it to complete essays and term papers, but is the world of medical research ready to have such artificial intelligence (AI) tools producing informed consent forms (ICFs) for clinical trial participants?

Compliance 64

Compliance Clinical Trials Clinical Trials Trials 64

ACRP blog

NOVEMBER 16, 2023

You may be happily using ChatGPT to produce meeting minutes or literature reviews, and your children may be secretly using it to complete essays and term papers, but is the world of medical research ready to have such artificial intelligence (AI) tools producing informed consent forms (ICFs) for clinical trial participants?

Compliance 52

Compliance Clinical Trials Clinical Trials Trials 52

Cloudbyz

MARCH 19, 2021

Study close-out is an essential factor in a clinical trial study. This process ensures that all the clinical trial activities are rightly reconciled, recorded, and reported at the end of the study trial. Why is study close-out important? Why is study close-out important?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MAY 22, 2020

If you are new to the clinical research industry, it’s important to know how clinical studies are developed and run. The basis for all such studies is the study protocol, about which this piece will provide a high-level overview. A study protocol is a document that provides an overview of the study.

Compliance 90

Compliance Clinical Research Drugs Research 90

Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The product was approved for use in adults, and the Pediatric Research Equity Act (PREA)-required pediatric studies were deferred.

Development 130

Development Production Drugs Marketing 130

pharmaphorum

DECEMBER 13, 2022

Over the past few years, many clinical study administrators wanted to use the bring your own device (BYOD) model within their eCOA, but they were typically constrained by regulatory requirements or misunderstandings around the approach. BYOD, therefore, offers several benefits for sponsors, researchers, and patients.

Clinical Trials 58

Clinical Trials Clinical Trials Compliance Trials 58

FDA Law Blog

MAY 19, 2023

Previously, the EUA template only required these studies for Multiplex Respiratory panels in which a new instrument was used with the proposed device; however this De Novo was for a simple point-of-care device to detect SARS-CoV-2 viral targets only. analytical, clinical and stability). analytical, clinical and stability).

Reagent 40

Reagent Genetics Contamination Marketing 40

Imperical Blog

JULY 1, 2020

How do you find people with a rare disease to volunteer for your trial? Here are two things to keep in mind when trying to recruit study subjects for a rare disease trial: Enlist Advocacy and Support Groups. As such, it is often very important to recruit these organizations in your efforts. Ask, how can we help you?

Trials 59

Trials Clinical Trials Clinical Trials Development 59

Cloudbyz

DECEMBER 31, 2021

In the most basic sense, all these terms refer to relatively mobile devices that you can wear on your person; designed to measure specific biological parameters in your body. Today, the most obvious example of wearable technology might be something like a fitness tracker worn on your wrist.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Manufacturing 52

World of DTC Marketing

MAY 13, 2021

One study analyzed the drug ads of an anti-hypertensive drug in 210 issues of the NEJM between 1985 to 1996 and showed increased ad frequency was associated with an increase in prescriptions. .” You can give them a list of doctors to target, and they will report metrics on how many of them have engaged your content.

Marketing 173

Marketing Pharma Companies Branding Doctors 173

XTalks

MAY 6, 2022

In 2019, the Tufts Center for the Study of Drug Development in collaboration with eClinical Solutions surveyed pharmaceutical companies about their developing and evolving clinical data demands. percent of the surveyed sponsors were using or piloting electronic health record (EHR)/electronic medical record (EMR) data and 35.5

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

Find Me Cure

SEPTEMBER 2, 2020

If you are a patient who is not satisfied with their current treatment, either because of severe side effects or because it doesn’t sufficiently relieve your symptoms, looking for an alternative can prove to be a challenge. . Difficulty getting connected to the study team. Lack of clear communication and transparency .

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

Advarra

AUGUST 14, 2023

As sites and sponsors look to create effective and robust participant experiences, they must evaluate and understand the existing perceptions. Financial compensation was listed as a participation motivator by 68% of survey respondents. Less than 12% of drugs and therapies entering clinical testing make it to approval.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

It ensures a patient-centric solution building some of them are listed below: Site Profile management with categorized study matrix, live tracking, centralized data, and process overview among others. Submissions and tracking of regulatory deliverables like investigator brochures, eConsent, study protocols, etc.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

It ensures a patient-centric solution building some of them are listed below: Site Profile management with categorized study matrix, live tracking, centralized data, and process overview among others. Submissions and tracking of regulatory deliverables like investigator brochures, eConsent, study protocols, etc.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

JUNE 10, 2020

If you’ve been involved in a start-up of a clinical study, you’re probably aware of the challenges that come with patient recruitment. A patient-facing study website provides patients and participants with a comprehensive list of actively recruiting studies across different therapeutic areas and disease conditions.

Clinical Trials 115

Clinical Trials Clinical Trials Trials Clinical Research 115

XTalks

DECEMBER 4, 2020

Ajay Srivastava, Senior Medical Director, Medical Department, and Carrie Sheil, Senior Director, Clinical Trial Management, both from Medpace, shared changes to the CKD treatment paradigm and offered advice on optimizing study design for CKD trials. Each of these complications represents separate areas of potential study.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

ACRP blog

DECEMBER 20, 2023

This is a sponsored message. Sponsors, contract research organizations (CROs), and sites all identify this as a significant hurdle, and one that leads to costly delays and mounting frustrations. Consider someone on the contracts team at either a sponsor or a site. It does not have to be that way.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

SEPTEMBER 25, 2023

A Unified Clinical Trial Management System is a solution that offers a CTMS software which can single-handedly manage the entire clinical study process with real-time visibility and analytics across study planning, budgeting, start up, study management, and close out.

Clinical Trials 87

Clinical Trials Clinical Trials Trials Compliance 87

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Placebo Control

MAY 30, 2013

You can't run your trial without patients, after all. Out of 108 trials identified, they managed to get – via search and direct inquiries with the trial sponsors – basic accrual data for only 43 (40%). Interestingly, exactly zero of the 32 industry-sponsored trials responded to the authors' initial survey.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Pharma Companies 40

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. The rapidly expanding landscape of cell therapy trials has put an operational strain on many clinical sites due to limited resources and infrastructure. “In

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. No sponsor is eager to submit a Field Alert Report (FAR). Camargo is always available to help navigate difficult situations like these with sponsors.

Development 232

Development Production Regulation Clinical Trials 232

Advarra

MAY 9, 2023

In today’s world of research, using a clinical trial management system (CTMS) can significantly streamline operations, and make for a more efficient research study. Do you know if you’re using your CTMS to its fullest capabilities? Below are some of the ways sites can get the most value from their CTMS platform.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Cloudbyz

JANUARY 14, 2022

A CTMS solution is a software solution that manages the tasks relating to clinical studies. CTMS solutions were the natural successors to consolidated databases, which study stakeholders started building to replace the vast quantities of individual files and spreadsheets they used to capture data for clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

XTalks

MAY 13, 2022

Charles Felter, Site Head at Curia New Jersey, LLC in Lebanon, NJ explains that the new USP chapters often require more testing than the original Chapter 661, which is part of the reason that USP granted an extension (until 2025) for full adoption in collaboration with external stakeholders. Stability Studies. Packaging Testing.

Packaging 98

Packaging Packaging Containment Production 98

Camargo

FEBRUARY 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. PREA did not apply because of orphan drug exclusivity, so crizotinib was not studied in pediatric patients at the time.

Development 131

Development Production Drugs Manufacturing 131

Cloudbyz

DECEMBER 9, 2021

By identifying patterns indicative of lower risk, RBM allows reduced monitoring visits to research sites when these visits are not necessary. RBM has a number of benefits, the most obvious being an increase in monitoring visits to research sites with identified higher risks that may disrupt data quality. The Problems. High Complexity.

Clinical Trials 52

Clinical Trials Clinical Trials Packaging Packaging 52

Cloudbyz

APRIL 28, 2022

A Unified Clinical Trial Management System is a solution that offers a CTMS software which can single-handedly manage the entire clinical study process with real-time visibility and analytics across study planning, budgeting, start up, study management, and close out.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52