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 52

Clinical Research Clinical Trials Research Trials 52

Conversations in Drug Development Trends

JULY 9, 2024

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. Glucagon also spares the GLP-1 effects potentially reducing side effects leading to increased compliance.

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Clinical Research Treatment Research Clinical Trials 52

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.

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Clinical Trials Trials Clinical Research FDA 98

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, (..)

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Clinical Trials Regulations Trials Pharmaceuticals 52

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

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Packaging Laboratories Pharmaceutical Companies Compliance 52

H1 Blog

JULY 30, 2024

The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements. Find out more by requesting a demo today.

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FDA Clinical Trials Compliance Pharma Companies 59

Vial

MAY 22, 2024

Introduction Veeva Systems and Vial CRO ( contract research organization ) represent stakeholders in the clinical research landscape, which play integral roles in the successful execution of clinical trials. Conclusion Vial CRO and Veeva Systems are tech-first solution providers in the clinical trial landscape.

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Clinical Trials Trials Clinical Research Compliance 52

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 52

Pharma Companies Clinical Trials Compliance Trials 52

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. However, it is often unengaging, cumbersome, and manual.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible.

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Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

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.

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Clinical Trials Trials Clinical Research Compliance 52

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.

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Laboratories Assay Development Small Molecule Drug Development 52

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.

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Trials Clinical Trials Regulations FDA 80

PPD

JUNE 29, 2023

My personal experience drives my passion to enable drug developers in the quest for better treatments with less complicated compliance requirements. Our experience in dermatological research is extensive, having performed more than 65 clinical trials with over 8,900 patients and more than 1,400 investigators worldwide.

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Clinical Trials Trials Drug Development Clinical Research 52

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.

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Clinical Trials Compliance Trials Laboratories 52

thought leadership

SEPTEMBER 12, 2023

In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever.

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Clinical Trials Trials Compliance Pharmaceuticals 40

Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. As von Itzstein et al.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

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.

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Clinical Trials Trials Clinical Development Clinical Research 40

PPD

JULY 9, 2024

Most industries have in common the need to meet strict timelines while also achieving quality and compliance standards and staying within budget. And it enables careful motoring of quality and compliance key performance indicators (KPIs), along with greater opportunity to apply time- and cost-saving process improvements.

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Compliance Production Clinical Research Marketing 52

Vial

MAY 8, 2024

As technological advancements drive the pharmaceutical industry forward, the shift towards digitalization, particularly with electronic data capture (EDC) systems, has become increasingly prominent. Vial seeks to transform clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes.

Clinical Trials 52

Clinical Trials Trials Clinical Research Laboratories 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.

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Clinical Trials Trials Science Production 52

Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. These services range from clinical study design and data management to statistical analysis and regulatory support.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

Advarra

SEPTEMBER 20, 2022

Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs). Reliable industry estimates peg the cost of these under-accruing sites to the pharmaceutical industry at between $600,000 to eight million dollars per day of trial delay.

Clinical Trials 52

Clinical Trials Trials Research Pharmaceuticals 52

Advarra

JUNE 9, 2022

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. How can we make clinical research more accessible to anyone who wishes to participate? Decentralized clinical trials (DCTs) can meet that need, but they come with some challenges.

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Clinical Trials Trials FDA Pharmaceutical Companies 52

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.

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Bioethics Clinical Research Regulations Clinical Trials 40

Molecule Blog

MARCH 17, 2023

The Primitives of Biomedical Discovery and Development It’s noteworthy that the majority of approved medicines, around 60%, have their roots in academia, with the remaining 40% stemming from pharmaceutical research and discovery. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

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Engineering Research Clinical Trials Government 52

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. It may also lead to decreased patient retention, which may result in significant delays to trial completion or loss of statistical power.

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Clinical Trials Trials Clinical Development Disease 52

The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” CTC optimizes “the management of clinical research carried out at the A.Gemelli Polyclinic,” EMA said, as well as giving clinical trial training and acting as an academic contract research organization.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

Clinical Trials 59

Clinical Trials Trials Clinical Research Disease 59

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). This acquisition has allowed the company to position itself as a global leader in clinical research services. launched a PV platform for clinical research registries.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Shah, M.D.,

FDA 59

FDA Clinical Trials FDA Compliance Production 59

Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

Clinical Trials 52

Clinical Trials Clinical Research Trials Compliance 52

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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FDA Science Regulations Production 40

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials. The file will head to the Parliament for a vote next. Device news is unsettled.

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Regulations Biosimilars Clinical Trials Production 40

The Pharma Data

DECEMBER 23, 2020

Astrea is a leading provider of affinity separation solutions to the pharmaceutical and biomanufacturing industries. Shanghai Haini Pharmaceutical — China’s Shanghai Haini Pharmaceutical Co., It is a division of Gamma Biosciences. Following the acquisition, the arivis5D content platform will be rebranded to neuronOS.

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Licensing Licensing Vaccine Trials 52