PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. Ongoing trials must transition to the EU CTR by Jan.

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Clinical Trials Regulations Trials Clinical Research 96

Drug Hunter

MAY 31, 2023

Capacity Bio’s MAS Receptor Agonists with $35M Raised for FIH Clinical Trials MAS modulator from WO2022165189 example 107 New start-up Capacity Bio backed by RA Capital, Insight Partners, and Remiges Ventures with $35 million funding is working on taking first-in-class mitophagy agonists into clinical trials, which are expected to start in 2024.

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Small Molecule Clinical Trials Trials Drugs 196

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

Clinical Trials 98

Clinical Trials Trials Compliance International 98

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

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Trials Disease Drug Development Clinical Trials 78

Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Trials Clinical Trials Licensing Licensing 97

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Trials FDA Regulations 105

Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Compliance Treatment 81

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.

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Clinical Trials Trials Clinical Research Doctors 86

Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Trials Disease Clinical Trials Clinical Research 75

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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FDA Trials Clinical Trials Disease 96

Drug Hunter

OCTOBER 5, 2023

If your company still isn’t one of the >300 institutions providing Drug Hunter Premium access to employees, you can request information and set up a trial for your team using the form below: Request a Trial Tell us how to reach you to discover more in an institution-wide free trial. The post Phase III is Coming!

Trials 247

Trials Drugs 247

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Clinical Trials Trials Government 64

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

Therapies 98

Therapies Trials FDA Clinical Trials 98

On Medicine

FEBRUARY 8, 2024

Why is the CHARMER trial important? The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards. What will happen during the CHARMER trial? The CHARMER approach will be tested in a stepped wedge trial in hospitals across England.

Hospitals 109

Hospitals Trials Doctors Clinical Research 109

PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

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Trials Clinical Trials Therapies Drug Development 63

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Clinical Trials Trials Clinical Research Treatment 52

On Medicine

NOVEMBER 27, 2023

The trial We are recruiting 66 educational settings and will involve 330 children and young people and their families. We have collected information which allows us to make sure that we are including settings from deprived areas which are often not included in research.

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Trials International Research 92

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.

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Clinical Trials Trials Compliance Clinical Research 52

Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.

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Clinical Trials Trials Clinical Research Research 52

ProRelix Research

SEPTEMBER 24, 2024

Biostatistics involves the application of statistical techniques for the design and analysis of clinical trial data.

Clinical Trials 52

Clinical Trials Trials Research Biosimilars 52

Drug Hunter

MAY 21, 2023

request a trial You don’t have time to read everything, but you can’t afford to fall behind. Drug Hunter Premium is drug discovery, distilled, so you can quickly catch up and make informed decisions based on industry examples. Get ahead now by requesting a trial. already a member?

Trials 144

Trials Drugs 144

Alta Sciences

OCTOBER 4, 2024

How We Tackle Immunomodulation in Clinical Trials blussier Fri, 10/04/2024 - 20:34 HTML The intricacies of immunomodulation in clinical trials can be complex, but our latest issue of The Altascientist breaks them down for you. In this issue, discover: The standard classes of immunomodulators and their roles in clinical trials.

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Clinical Trials Trials 52

Vial

JUNE 12, 2024

Introduction Patient-reported outcomes (PROs) refer to information about a patient’s health that is shared directly by the patient and not influenced by the interpretation of any other. What are PROs in clinical trials? These aspects influence a patient’s perceived health-related quality of life (QoL).

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Clinical Trials Trials FDA Clinical Research 52

thought leadership

JULY 2, 2024

Change in the Submission of the Summary Notification Information Format The Summary Notification Information Format Form As of January 31, 2023, Sponsors are required to submit a Clinical Trial Application (CTA) in the EU through the Clinical Trial Information System (CTIS).

Therapies 52

Therapies Trials Clinical Trials Regulations 52

PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. Finally, patients want to feel informed about and valued in the study.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Drug Hunter

MAY 21, 2023

request a trial You don’t have time to read everything, but you can’t afford to fall behind. Drug Hunter Premium is drug discovery, distilled, so you can quickly catch up and make informed decisions based on industry examples. Get ahead now by requesting a trial. already a member?

Targeted Protein Degradation 131

Targeted Protein Degradation Trials Therapies Disease 131

Conversations in Drug Development Trends

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

Clinical Trials 52

Clinical Trials Trials Disease Drug Development 52

Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. The industry faces several persistent hurdles: Data fragmentation: Research teams often struggle with siloed information across departments, hindering collaboration and comprehensive analysis.

Clinical Trials 52

Clinical Trials Trials Science Production 52

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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Clinical Trials Regulations Trials Pharmaceutical Companies 52

Advarra

AUGUST 21, 2024

Today, projects can be edited by multiple people in real time, and the latest information is available on any device with an internet connection. Nowhere is this more painful than in clinical trials, the backbone of drug development. Few technologies have radically changed the way we do business as electronic workflows.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Drug Hunter

JUNE 26, 2023

III trial ( NCT05099640 ; n=98, 7.5-60mg/kg Another THR-Beta Positive Readout in N ASH request a trial You don’t have time to read everything, but you can’t afford to fall behind. Drug Hunter Premium is drug discovery, distilled, so you can quickly catch up and make informed decisions based on industry examples.

Small Molecule 130

Small Molecule RNA Trials Treatment 130

Drug Hunter

MAY 22, 2023

request a trial You don’t have time to read everything, but you can’t afford to fall behind. Drug Hunter Premium is drug discovery, distilled, so you can quickly catch up and make informed decisions based on industry examples. Get ahead now by requesting a trial. already a member?

Drugs 133

Drugs Trials Disease 133

Agency IQ

AUGUST 23, 2024

AgencyIQ summarizes the noteworthy changes in the updates to several documents designed to help sponsors and other entities involved with clinical trials to transition to the Clinical Trials Information System (CTIS) on January 30, 2025. Fill out the form to read the full article.

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Clinical Trials Trials 52

PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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Trials Clinical Trials Clinical Development Clinical Research 52