Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

Clinical Research

PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Whatever the reason behind a patients fatigue, education and encouragement are key to continued engagement.

Clinical Trials

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

Clinical Research

LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

Clinical Research

ProRelix Research

APRIL 17, 2025

Indiaprovidesanidealsettingforsuchcost-savingstrategiesduetoseveralkeyfactors: Economic Benefits Conducting trials in India can reduce costs by up to 60%comparedtoWesterncountries.Labor costs,participantrecruitment,hospitalinfrastructure,andadministrativefeesaresignificantly lower. […] The post Outsourcing Clinical Trials to India: Global Regulation, (..)

Clinical Trials

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

Clinical Research

Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

Clinical Research

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

Clinical Research

PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Respondents shared their perspectives on the successes and challenges of DCTs and hybrid clinical trials.

Clinical Trials

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). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

Clinical Trials

Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

Trials

KIF1A

JULY 1, 2023

This activity may be regulated by the K-loop, which is known to be important for KIF1A’s long-range movement. But drug R&D is an uncertain process, and many therapeutics get shelved during preclinical or clinical research, before they ever reach a patient.

Small Molecule

Crown Bioscience

MAY 4, 2021

Pediatric cancer has been a low priority for pharmaceutical companies due to a combination of factors, including scientific hurdles, additional regulatory burdens, and financial disincentives. Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e.

Research

Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources.

Pharma Companies

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. PPD ® Laboratory services are backed by a proven track record with over three decades of experience providing CMC pharmaceutical testing.

Laboratories

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research

Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. Regulatory Excellence - Licenses for Schedule I through IV drug substances.

Compounding Pharmacies

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.

Clinical Trials

The Pharma Data

JANUARY 24, 2021

Their world-class physicians set new standards in comprehensive urologic patient care and continue to innovate with the most advanced treatments backed by clinical research. FACOS, Director of Clinical Research for MU stated “We are excited to work with Theralase for the NMIBC clinical study. Dr. Laurence H.

Pharmaceutical Companies

Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

Clinical Trials

The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. Therefore, it is expected to bring more clinical benefits to patients with diabetes and metabolic syndrome.

Pharmaceuticals

Perficient: Drug Development

JULY 24, 2023

How are you making a difference for our clients, colleagues, and communities? As a lead business consultant in the computer system validation department, I plan, write, implement, and review the computer systems validation plan and protocols within highly regulated industries. Thanks for joining me today, Kaushal.

Regulations

Drug Target Review

SEPTEMBER 26, 2023

She completed a PhD at Durham University which focused on investigating the mechanisms of cardiotoxicity of cancer therapies using clinically relevant in vitro human models of cardiac physiology paired with novel methodologies to evaluate structural and functional toxicities. Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP.

Drugs

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials

The Pharma Data

DECEMBER 17, 2020

Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

Small Molecule

Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development. Everyone may use different software systems to manage these documents.

Clinical Trials

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Regulators and payors also demand a higher volume of data collection for these studies.

Trials

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

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science

NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

Clinical Trials

H1 Blog

NOVEMBER 29, 2023

The initial report, which came out In 2013 from PhRMA/EFPIA, recognized the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote scientific advancements. This is especially true for registries outside of the United States where data is not as strictly regulated.

Clinical Trials

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. However, they also bring unique regulatory challenges.

Trials

The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies.

Bioethics

Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

Clinical Trials

Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

FDA

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. About PXL770.

Trials