PPD

FEBRUARY 10, 2025

Todays clinical trials rely on technologically sophisticated systems that require complex integrations to capture and process all manner of data across multiple sites, often spread throughout multiple countries or jurisdictions. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

Clinical Trials

Advarra

MAY 21, 2025

Many pharma companies are unsure how to begin aligning with the new expectations, especially around trial design and quality systems. Our advice is to begin with a thorough review of your documentation, then once the gaps are identified, updates can be planned and implemented. What needs to change? Are we ready for inspection?

Pharma Companies

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

Drug Development

The Pharma Data

JUNE 12, 2025

The trial evaluated 125 patients with relapsed or refractory AML, as well as those who were newly diagnosed but ineligible for intensive chemotherapy — all with KMT2A-rearrangements or NPM1 mutations. The most commonly documented Grade 3 or higher TEAEs were thrombocytopenia (59%), neutropenia (59%), and anemia (49%). Source link

Treatment

PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. It automates repetitive tasks such as documentation, summarization and annotation — significantly improving efficiency.

Clinical Research

Advarra

JULY 3, 2025

Designed to better manage risk, patient safety, and data integrity in clinical trials, the updated guideline is expected to be adopted by regulatory authorities worldwide. Read on to explore how ICH E6 (R3) may affect your ongoing and future trials—and use the following 10 critical categories of questions to assess your readiness.

Compliance

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. Documentation/medical writing : Regional regulatory agencies (such as the U.S. The biotech industry is a dynamic sector, rapidly evolving and poised for continued growth.

Clinical Development

The Pharma Data

JUNE 18, 2025

Emprove® Program – Designed to support regulatory compliance and quality assurance, the Emprove® framework provides detailed documentation for raw materials, process chemicals, and single-use products, making regulatory filings more efficient and transparent.

Therapies

Alta Sciences

NOVEMBER 15, 2024

Whether you’re at the discovery phase or gearing up for a clinical trial , your first conversation with a CRO is an excellent opportunity to assess the cultural fit and collaborative potential. Let the CRO know any key outcomes from each. IND, CTA, NDA, BLA). “If

Drug Development

Alta Sciences

MARCH 4, 2025

Many of the groups achievements have included raising critical challenges in study design and data interpretation, and providing feedback and suggestions to draft FDA guidance documents. Tags Clinical Trials Weight 16 I have spent the better part of my career working to make drugs safer.

Clinical Trials

Alta Sciences

FEBRUARY 19, 2025

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

Drug Development

The Pharma Data

JUNE 16, 2025

Neurologic events (NE) of any grade were documented in 33% of patients, with Grade 3 NEs in 4% and no Grade 4 or 5 NEs. Poster Session (Friday, June 20) : Optimizing post–chimeric antigen receptor T-cell monitoring: Evidence across lisocabtagene maraleucel pivotal clinical trials and real-world experience.

Therapies

The Premier Consulting Blog

DECEMBER 10, 2024

By the time of NDA submission, a sponsor should be able to demonstrate that the clinical materials used in pivotal trials are representative of the proposed commercial processes and product. Stability studies are initiated to support clinical trial material and continue to support the intended final formulation in the NDA and after approval.

Marketing

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials.

Drug Research

Advarra

DECEMBER 17, 2024

AI can also automate labor-intensive tasks, such as extracting key information from protocol documents to populate downstream systems. For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed.

Clinical Research

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Any delays or missteps in bioanalysis during a Phase I trial can derail the trajectory of a promising drug.

Clinical Trials

The Pharma Data

JUNE 15, 2025

Infections were documented in 18 patients (58% of the study population), with 5 cases (16%) classified as serious; none resulted in a grade 5 event (death related to the study treatment).

Therapies

Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Therapies

DrugBank

JUNE 18, 2025

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

Drug Development

The Pharma Data

JUNE 16, 2025

The approval by the FDA is supported by data from the pivotal, placebo-controlled VANGUARD Phase 3 trial , which was designed to evaluate both the efficacy and safety profile of ANDEMBRY. The most frequently reported adverse reactions (with an incidence greater than or equal to 7%) in the pivotal trial were nasopharyngitis and abdominal pain.

FDA Approval

PPD

JULY 18, 2025

Effective communication with regulatory authorities is critical for small biotech companies, as it is often the key to success in clinical trials. Prepare questions that are aligned with existing guidance documents, regulations and agency precedents — to demonstrate an understanding of the applicable framework and scientific rigor.

Regulations

Codon

JULY 28, 2025

That year, Terrence Flotte’s team at Johns Hopkins University used a natural strain of AAV, called AAV2, to introduce a cystic fibrosis transmembrane conductance regulator (CFTR) gene — defective in those with cystic fibrosis — into patients during a phase 1 clinical trial.

Immune Response

The Pharma Data

JUNE 20, 2025

While effective at suppressing inflammation, long-term corticosteroid use comes with a host of well-documented side effects—particularly concerning in the elderly—such as osteoporosis, diabetes, hypertension, infections, and adrenal suppression. For many years, systemic corticosteroids have been the mainstay of BP treatment.

FDA Approval

Codon

APRIL 14, 2025

They could also help bootstrap online communities and create tooling for sharing and iterating on improved protocols through videos and detailed documentation, similar to how programmers share code improvements and speedrunners share both their runs and strategies to achieve them. Learning requires trial, error, and revision.

Protein Expression

FDA Law Blog: Biosimilars

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

Drugs

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.

Clinical Trials

thought leadership

JUNE 30, 2025

In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the integrity of the research process. The EU Clinical Trial Regulation (CTR) (No.

Clinical Trials

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

Therapies

Drug Patent Watch

JANUARY 8, 2025

It typically begins with the filing of a patent application and extends through various stages: Discovery and initial patent filing Clinical trials and regulatory approval Market exclusivity period Patent expiration and generic competition Understanding this lifecycle is crucial for developing a strategy that maximizes protection at every stage.

Pharmaceutical Companies

Advarra

MARCH 7, 2025

Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. Advancement in treatment of diseasesfrom cancer to diabetes to rare diseaseshave all come about because of clinical trials.

Clinical Research

Codon

JULY 14, 2025

Stone documented his use of it, but it was by no means a widespread curative. However, in a Bayer management meeting to discuss whether acetylsalicylic acid should go forward to clinical trials, Dreser asserted that it was a direct cardiac poison and opposed it progressing to trials. So why did Eichengrün wait?

Treatment

FDA Law Blog: Biosimilars

APRIL 22, 2025

The hearing closely resembles a trial, but the ALJ (rather than a jury) is the trier of fact. DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents. What Resources Are Available?

Testimonials

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. This is where contact center services play a vital role.

Clinical Trials

PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. 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.

Clinical Trials

PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. Ongoing trials must transition to the EU CTR by Jan.

Clinical Trials

PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. The increase in complexity isn’t just creating challenges for patients.

Clinical Trials

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Clinical Trials