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.

Trials 58

Trials Clinical Trials Therapies Drug Development 58

PPD

OCTOBER 21, 2024

Our white paper on the topic examines reasons biotech companies use the functional service provider (FSP) model to support their clinical development activities and the value that FSP engagements bring to these organizations. With FSO, all tasks for a clinical trial are outsourced. are outsourced.

International 76

International Clinical Development Clinical Trials Clinical Research 76

Conversations in Drug Development Trends

APRIL 4, 2024

Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research. To take a deeper dive into these guidelines, read our Q&A white paper , where industry-leading experts answer some common questions on bioanalytical guidance.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

Conversations in Drug Development Trends

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinical trials.

Clinical Research 52

Clinical Research Research Clinical Trials Treatment 52

PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs 1.

Clinical Trials 52

Clinical Trials Trials Drug Development Treatment 52

Advarra

MAY 26, 2023

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.

Clinical Research 52

Clinical Research Trials Clinical Trials Research 52

The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Clinical Research 52

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

Conversations in Drug Development Trends

NOVEMBER 21, 2023

We thought, thousands of drugs haven’t been researched for thousands of other indications, so how can we disrupt the model? Dr. Fajgenbaum was determined to live, so he set out to leverage his limited medical training, scouring existing research literature and studying his body to find a treatment.

Disease 78

Disease Treatment Clinical Trials Clinical Development 78

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

EG Life Sciences

FEBRUARY 15, 2023

It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. Thanks for connecting with us, and we invite you to continue checking in to the EG Life Sciences Content Library for additional interesting blogs, white papers, and more.

Drug Development 52

Drug Development FDA Approval Drugs Virus 52

The Pharma Data

SEPTEMBER 11, 2020

Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease. The Covid-19 command center was created to provide sponsors of clinical trials pursuing in-house Covid-19 research with an AI-powered data analytics platform. Saama Technologies, Inc. ,

Clinical Trials 52

Clinical Trials Pharma Companies Trials Hospitals 52

Conversations in Drug Development Trends

MARCH 1, 2023

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. See how to unlock the full power of your CRO partner in our white paper, Optimal Outcomes in Clinical Research and Product Development.

Clinical Research 52

Clinical Research Clinical Trials Science Trials 52

Conversations in Drug Development Trends

AUGUST 14, 2024

Recent Advancements in Biomarker Research The latest advancements in biomarker research have further elevated the biomarker’s role in disease diagnosis, treatment, and monitoring. Check out our white paper to learn more about our services, or contact our team to find out how we can help support your oncology drug development program.

Treatment 78

Treatment Therapies Disease Protein Expression 78

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

PPD

JULY 16, 2024

Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions. This research ultimately influenced the creation of a new submission process for the client.

Compliance 52

Compliance Regulations Production International 52

PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) This approach enables unbroken continuity of support and resources across clinical trial operations.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Read our white paper to learn the keys to successfully implementing functional service partnerships.

International 52

International Research Drug Development Pharmaceuticals 52

Agency IQ

JULY 21, 2023

The assessment of this benefit typically relies upon the use of specific endpoints to measure this clinical benefit, generally within the context of a clinical trial. [ OS is an outcome-related endpoint that is defined as the time from trial randomization until death from any cause in the intent-to-treat population.

FDA 40

FDA Clinical Trials Treatment Trials 40

Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. Nucleic Acids Research. Nucleic Acids Research. ” Nucleic Acids Research. . ” Nucleic Acids Research. PLOS Computational Biology.

Vaccine 52

Vaccine DNA Engineering RNA 52

Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. Nucleic Acids Research. Nucleic Acids Research. ” Nucleic Acids Research. . ” Nucleic Acids Research. PLOS Computational Biology.

Vaccine 52

Vaccine DNA Engineering RNA 52

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

Regulations 40

Regulations Trials Clinical Trials Science 40

Agency IQ

FEBRUARY 21, 2024

Given the widespread use of CDISC for clinical research and HL7 for electronic health record (EHR) data, the two organizations have partnered to create mapping guides to streamline the flow of data from EHRs to CDISC submission-ready datasets, and vice versa. CMS in the United States ).

Science 40

Science Regulations International FDA 40

PPD

NOVEMBER 25, 2024

Clinical trials are critical for advancing medical research and bringing new treatments to market. These trial locations, despite being activated, fail to enroll participants, leading to increased costs, delays and potentially compromised trial outcomes.

Clinical Trials 54

Clinical Trials Trials Clinical Research Drug Development 54

Alta Sciences

OCTOBER 28, 2024

White Paper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. Read the white paper. This fact sheet highlights how our expertise in site selection directly contributes to your clinical trials.

Science 52

Science Clinical Trials Trials FDA 52

PPD

NOVEMBER 18, 2024

For example, a biotech developer creating a new antiviral drug could miss a change in one aspect of a regulatory requirement, only to discover at the end of the process that they must restart a clinical trial or resubmit portions of their data.

Clinical Trials 52

Clinical Trials Regulations Compliance Production 52

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. A Florida trial court, in Brookes v. Defendant] has not argued, let alone shown, that [plaintiff] cannot prevail under that theory. Jane Doe No.

Production 52

Production Trials International Government 52