Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. Outdated systems: Many organizations rely on legacy data management tools that fail to meet the demands of modern clinical trials.

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DS in Pharmatics

OCTOBER 17, 2024

These specialists offer essential expertise in drug development, clinical trial design, regulatory compliance, and market strategy. Improve your pharmaceutical product’s chances of success by engaging a biopharmaceutical consultant.

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Clinical Trials Compliance Drug Development Pharmaceuticals 52

Vial

MAY 13, 2024

Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 An estimated 80% of clinical trials do not finish on time.

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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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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.

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PPD

JUNE 29, 2023

Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.

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Clinical Trials Trials Drug Development Clinical Research 52

thought leadership

AUGUST 19, 2024

In the context of clinical-phase drug manufacturing, QA encompasses a range of activities designed to ensure that investigational drugs are produced consistently and meet the stringent requirements necessary for clinical trials.

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Compliance Clinical Trials Drugs Drug Development 52

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.

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Clinical Trials Trials Clinical Research Research 52

H1 Blog

JULY 19, 2023

Streamlining recruitment and reporting to support advanced oncology drug development In March of 2023, the U.S. In order to qualify for accelerated approval, drug manufacturers must demonstrate that the medication provides meaningful clinical benefit to patients with life-threatening illnesses during their clinical trials.

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Clinical Trials Trials FDA Treatment 52

H1 Blog

JULY 30, 2024

Increasing diversity in clinical trials not only makes the findings more relevant to various patient groups, but also enhances knowledge about the disease or medical product being studied. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

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FDA Clinical Trials Compliance Pharma Companies 59

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly ten years to go from clinical testing to approval. First let’s look at some challenges and then opportunities.

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Trials Clinical Trials International Regulations 59

Alta Sciences

OCTOBER 28, 2024

TOP CLINICAL SCIENTIFIC RESOURCES Video: The True Meaning of Moving in Unison Watch how collaboration and precision ensure seamless clinical trial implementation. The study used a double-blind, crossover design with recreational drug users to evaluate subjective effects and likability. Read the white paper. Read the blog.

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Science Clinical Trials Trials FDA 52

PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Strategies to Increase Diverse Populations in Dermatology Clinical Trials 1. ” Adding to this momentum, in December 2022 the U.S.

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Clinical Trials Trials Clinical Research Disease 59

Conversations in Drug Development Trends

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. Patient Compliance One of the most important findings of the study was the difference in patient compliance between the two sample collection methods.

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DNA Compliance Clinical Trials Trials 72

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. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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Alta Sciences

AUGUST 7, 2024

blussier Wed, 08/07/2024 - 19:51 HTML Timing is Everything Early collaboration with an experienced CDMO is crucial in drug development to mitigate manufacturing risks and ensure the efficient formulation of your API for preclinical and clinical testing. Contact us today to discuss the next stage of your drug development journey.

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Alta Sciences

JULY 10, 2024

Surveys have shown that patients prefer dermal routes of administration, and so dermal and transdermal drug delivery systems (TDDS), also known as patches, can provide greater patient compliance, ease of administration, and convenience—especially for conditions in which chronic use is necessary.

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Clinical Trials Compliance Trials Drug Development 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. over the forecast period (2022-2030).

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Pharma Companies Clinical Trials Compliance Trials 52

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. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

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Clinical Research Clinical Trials Research Trials 52

Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Alta Sciences

JULY 18, 2024

Inside The Altascientist: How to Achieve Optimal Preclinical Formulation and Drug Product Manufacture aasimakopoulos Thu, 07/18/2024 - 20:33 Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials.

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Production Clinical Trials Compliance Drugs 52

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. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

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Clinical Trials Trials Clinical Research Compliance 52

PPD

OCTOBER 4, 2023

Running a clinical trial is a long and tumultuous process requiring trial sites and sponsors to sift through various challenges. Identifying, preempting and overcoming emerging issues and bottlenecks, reducing site burden, and improving the overall efficiency of a trial through continued improvements are just a few examples.

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Clinical Trials Trials Compliance Laboratories 52

Alta Sciences

DECEMBER 13, 2023

Get Improved Bioavailability and Stability With This Dosage Form blussier Wed, 12/13/2023 - 22:36 HTML The choice of dosage form in drug development depends on various factors, such as the properties of the API, the therapeutic goals, and regulatory considerations.

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Conversations in Drug Development Trends

APRIL 25, 2024

However, the collection of accurate and reliable data in these pain studies presents a unique set of challenges, from the subjective nature of pain to the variability in patient compliance and assessment methodologies. However, further improvements are needed , including: Refinement of trial designs that address specific factors (e.g.,

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Clinical Trials Compliance Trials Clinical Research 52

Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Let the CRO know any key outcomes from each.

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Drug Development Clinical Trials Trials Compliance 52

Advarra

APRIL 4, 2024

One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial.

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Clinical Trials Pharmaceutical Companies Trials FDA 52

Metabolite Tales Blog

DECEMBER 19, 2023

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

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Pharma Companies Drug Development Compliance Trials 52

The Pharma Data

OCTOBER 25, 2020

26, 2020 /PRNewswire/ — Gmax Biopharm today announces that the first dose of GMA301 was given to the patient in its phase 1B trial to investigate the drug efficacy to treat pulmonary arterial hypertension (PAH). GMA 301 is the first antibody drug for PAH treatment. Orphan drug designation has been granted by FDA.

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Trials Clinical Trials Drugs Compliance 40

Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

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Conversations in Drug Development Trends

APRIL 8, 2024

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success.

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Clinical Trials Clinical Research Trials Compliance 75

Vial

MAY 1, 2024

The landscape of medical research is currently in the midst of an exciting transition wherein technology has rapidly become a critical tool for clinical trial management and patient data collection. in 2010 to 11.4% in 2020 to enable continuous remote monitoring of real-world patient health data. in 2010 to 11.4%

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Clinical Trials Trials Compliance Engineering 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. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By geographical region, the global CRO services market in 2023 was dominated by North America.

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Clinical Trials Clinical Research Trials Laboratories 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. million data points.”

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PPD

DECEMBER 12, 2023

Drug developers using functional service partnerships (FSPs) are taking an increasing interest in the follow-the-sun business model to optimize operations, transitioning work across global locations as the sun rises and sets. Clinical trials often engage patients located in different global regions.

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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. This high attrition rate directly results from the scientific and regulatory hurdles that drug candidates must overcome.

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