Conversations in Drug Development Trends

APRIL 25, 2024

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%.

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PPD

AUGUST 5, 2024

Though they do positively impact patients’ quality of life and hemodynamic parameters, these treatments — prostacyclin analogs and receptor agonists, phosphodiesterase 5 inhibitors, endothelin-receptor antagonists, and cGMP activators — have shown limited beneficial effects on survival and disease progression.

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PPD

JUNE 24, 2024

Explore the unique aspects of mega trials, the challenges they pose to vaccine developers, what the future holds for these large, complex trials, and how a partnership with an experienced provider of clinical research solutions can enable success.

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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.

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an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. One such approach is standardizing imaging protocols across your trial sites — consistency is key.

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PPD

OCTOBER 31, 2024

In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. This approach is reshaping clinical trials and therapeutic development, offering more targeted and effective solutions.

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Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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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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Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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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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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

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Conversations in Drug Development Trends

AUGUST 9, 2024

It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.

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Perficient: Drug Development

SEPTEMBER 25, 2024

Collaboration barriers : Disparate teams often struggle to share insights and work cohesively, slowing down the research process. Regulatory compliance : Keeping up with evolving data management regulations adds another layer of complexity to clinical trials.

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Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. R3 acknowledges no clinical trial can be flawless, but it encourages organizations to adapt their processes and systems to address the most critical risks effectively.

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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.

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Conversations in Drug Development Trends

MARCH 20, 2024

As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials. However, certain variants may not metabolize this blood thinner as efficiently, rendering the treatment less effective in those participants.

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PPD

OCTOBER 9, 2023

Adverse event identification: A patient called his concierge stating that he had been experiencing severe nausea while on treatment and would need to leave the trial. The concierge expressed empathy for the participant’s symptoms, and then offered to transfer the participant to his clinical trial site.

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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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PPD

AUGUST 9, 2023

Harmonized Clinical Trial Data Structures to Drive Innovation within Decentralized Clinical Trial Models Data is the fuel of the digital enterprise — it is the lifeblood needed to execute key processes, make decisions and achieve regulatory compliance. Logically, both outcomes cannot be observed in the same patient.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 However, pain treatment shouldn’t resort to a “whatever it takes” approach. Instead,  Collaborating with patients plays a fundamental role, as each treatment discussion and decision-making process varies based on individual patients.  Pain is not simple; it is not just mere unpleasantness that can be remedied with a pill.

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PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders.

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Vial

DECEMBER 11, 2023

Despite the essential role of the clinical research industry, initiating a clinical study at a new site often takes a considerable amount of time, which can postpone the overall timeline of the research. These documents are reviewed to ensure they are in compliance with ethical guidelines. Observational.

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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.

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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. Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials.

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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. Compliance also assures the credibility of the clinical data.

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Vial

DECEMBER 13, 2023

The 2023 State of Clinical Trial Technology Report by Florence Healthcare presents insights from 450 clinical research sites, sponsors, and CROs. Automation contributes significantly to financial visibility, cash flow predictability, and regulatory compliance, enabling financially aware decisions and improved budget management.

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Advarra

JUNE 13, 2024

Synthetic mRNA-based therapeutics used in clinical research today also fall into this self-limiting class of recombinant therapeutics. Clinical personnel need to understand these risks and how risks are differentiated between healthy and vulnerable individuals. These IPs pose the lowest risk amongst all recombinant IPs.

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Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What Does an IBC Review?

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The Premier Consulting Blog

NOVEMBER 20, 2023

Rigorous Compliance Ahead: If LDTs fall under the IVD umbrella, they would be subject to the FDA’s medical device regulatory requirements. This sea change will necessitate a proactive strategy from regulatory professionals, ensuring compliance at each step. Correction and removal reporting requirements.

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Advarra

APRIL 27, 2023

Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and well-functioning society, the benefits of research would ideally be shared equitably among all social groups, regardless of race, age, gender, or ethnicity. This gives the research community (e.g.,

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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. For such tests, neither the FDA nor many IRBs enforce compliance with the medical device regulations.

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The Pharma Data

NOVEMBER 10, 2020

Hydrogen-Oxygen Inhalation for Treatment of COVID-19, a monograph concluding China’s experience in the fight against COVID-19, reports that Hydrogen Oxygen Generator with Nebulizer is effective in treating patients with COVID-19 coronavirus. SHANGHAI , Nov. It is expected to be certificated CE Mark soon.

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The Pharma Data

NOVEMBER 10, 2020

We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.”.

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Advarra

JUNE 5, 2023

In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant safety by convening a data safety monitoring board (DSMB), sometimes called a data monitoring committee (DMC) or independent safety monitoring board (ISMB).

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PerkinElmer

JANUARY 25, 2023

This also dovetails with the core need to meet the rigors of compliance and audit trails to help support safety for patients.” Recent publications explore the power of such systems to better predict clinical safety at the pre-clinical stage. The emerging field of metagenomics in clinical research settings also shows promise.

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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. If you’re facing regulatory challenges or simply looking for guidance on your clinical development strategy, meet us at the upcoming ASCO conference.

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