Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.

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PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

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PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Clinical Trials Trials Clinical Research Research 52

Quanticate

JUNE 13, 2024

The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.

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Clinical Trials Laboratories Regulations Clinical Research 59

thought leadership

SEPTEMBER 30, 2024

If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical Evaluation Report. In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER). Let’s get started.

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Olympian Clinical Research

SEPTEMBER 3, 2020

Sleep is especially important in regulating mood. Finding the right medication can be a frustrating process, though, since there’s no “one-size-treats-all” medication for depression on the market. The post Battling Depression In A World Of Isolation: Tips For Managing COVID Depression appeared first on Olympian Clinical Research.

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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.

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PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. This includes everything from clarifications sought from individual regulatory authorities to Q&A documents, other professional publications and conference presentations.

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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. Fortunately, leading global regulators have launched key initiatives.

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PPD

SEPTEMBER 6, 2023

Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?

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Vial

FEBRUARY 21, 2024

Medical devices have seen a significant increase in market demand for the past few years. Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. These companies are equipped with the expertise and resources to lead successful medical device clinical trials.

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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. At a February 2024 joint workshop with the U.S. Next, the U.S.

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Vial

FEBRUARY 15, 2024

To address these challenges, many companies outsource their clinical trials to contract research organizations (CROs) with established protocols, global reach, and therapeutic area expertise1. The demand for clinical trial outsourcing services is on the rise. over the forecast period (2022-2030).

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Conversations in Drug Development Trends

AUGUST 23, 2023

To spur more frequent engagement between patients, sponsors, and regulators, Richie Kahn and Jenn McNary co-founded Canary Advisors , a patient engagement consultancy that works to better align development programs with patient needs.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Expanded Definition: FDA aims to reshape the boundaries of IVDs within 21 CFR Part 809.3.

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Laboratories Clinical Development FDA Regulations 52

Crown Bioscience

MAY 4, 2021

In addition, owing to the rarity of these diseases, it can be extremely challenging to gain to patients and perform the clinical research necessary for regulatory approval. Classified as "orphan diseases", pediatric cancers account for around 1% of all cancers in the US.

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Advarra

APRIL 19, 2023

IVDs are used in almost all clinical research. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.

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Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role.

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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. In many cases, higher levels of sponsor oversight are even required by regulation.

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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. new medicines. Postmarketing Commitments.

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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. We can manufacture almost every dosage form on the market. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials

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The Pharma Data

DECEMBER 21, 2020

” Kaiser Permanente’s elimination of member out-of-pocket costs applies to all fully insured benefit plans, in all markets, unless prohibited or modified by law or regulation. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health.

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Virus Clinical Research Treatment Disease 52

Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 To learn about the history of these trial technologies and their adoption within the clinical research industry, read more here !

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Clinical Trials Clinical Research Trials Hospitals 52

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Fair market value: Do some research prior to negotiations to establish the standard pricing for supplies and services, and make sure the budget reflects fair market value.

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PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

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Compliance Clinical Research Trials Clinical Trials 52

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.

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Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

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Trials Clinical Trials Compliance Treatment 81

Perficient: Drug Development

JULY 24, 2023

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. I consider Perficient to be the best in the regulated and technology consulting industry. Thanks for joining me today, Kaushal.

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thought leadership

SEPTEMBER 5, 2023

By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070.

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H1 Blog

NOVEMBER 29, 2023

Every day, patients around the globe are waiting for life-saving treatments to reach the market. 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.

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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.

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Trials Clinical Trials Therapies Treatment 52

PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money.

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The Pharma Data

OCTOBER 14, 2020

The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”. market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years.

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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.

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The Pharma Data

NOVEMBER 11, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada. Source link.

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The Pharma Data

DECEMBER 16, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada. Source link.

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Therapies Disease Marketing Clinical Research 40