PPD

JULY 18, 2025

Prepare questions that are aligned with existing guidance documents, regulations and agency precedents — to demonstrate an understanding of the applicable framework and scientific rigor. This enables drug developers to define their objectives clearly for every meeting and curate and structure briefing materials with precision.

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Regulations Drug Development Clinical Trials Research 52

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.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.

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Clinical Trials Trials Clinical Research Government 88

Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. 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. It is the foundation of medical innovation.

Clinical Research 52

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Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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Clinical Research Research Clinical Trials Compliance 98

Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What is an Electronic Master File (eTMF)?

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Research Clinical Trials Compliance Regulations 52

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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Clinical Research Research Compliance Clinical Trials 52

Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

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Clinical Research Research Clinical Trials Trials 52

PPD

JUNE 10, 2024

We are thrilled to announce that the PPD clinical research business of Thermo Fisher Scientific is getting a brand refresh! Our new visual identity will align more closely with Thermo Fisher’s style, while still retaining elements unique to our PPD clinical research business. Ready to unlock efficiencies?

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Clinical Research Research Drug Development Therapies 52

Advarra

MARCH 14, 2023

Maintaining regulatory compliance at research sites and institutions is no small feat – documents need to be updated and maintained in a consistent manner to ensure compliance. Advarra’s eRegulatory Management System (eReg) is designed to adapt to and streamline research site regulatory workflows.

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Clinical Research Research Compliance Clinical Trials 52

Quanticate

MAY 21, 2020

This blog focuses on regulatory writing, which involves the preparation of clinical study and regulatory submission documentation. There are two main areas in medical writing, medical communications and regulatory writing.

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Clinical Research Research Clinical Trials FDA 52

Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

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Clinical Research Research Clinical Trials Regulations 52

PPD

FEBRUARY 19, 2024

Phase 1 : EU CTR Impact Analysis Develop a project charter to document goals, scope, constraints and boundaries, risks, and milestones. Ensuring high quality trial documentation, minimizing the inclusion of commercially confidential information (CCI) and personal protected data where possible.

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Clinical Trials Regulations Trials Clinical Research 96

thought leadership

SEPTEMBER 30, 2024

However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER).

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Regulations Marketing Clinical Research Research 98

On Medicine

FEBRUARY 8, 2024

As noted, older people are under-served by clinical research and CHARMER has made a concerted effort to involve public and patient representatives in all CHARMER study activities, including as co-applicants. What will happen during the CHARMER trial?

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Hospitals Trials Doctors Clinical Research 109

PPD

OCTOBER 17, 2024

Drug developers of all sizes are working to optimize each step in the clinical research process from site selection to complex logistics, managing evolving regulations, and patient recruitment and retention strategies. There is a race in the field to overcome these challenges to enable the success of CGT products in Asia-Pacific.

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Quanticate

SEPTEMBER 2, 2024

Clinical research serves as the foundation for advancing medical knowledge, improving patient care, and ensuring the safety and efficacy of new investigational products. One document which plays an essential role in the safety, traceability and overall validity of a clinical trial is the Statistical Analysis Plan (SAP).

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Clinical Trials Trials Clinical Research Production 52

Conversations in Drug Development Trends

APRIL 8, 2024

Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research. Our cohesive approach, characterized by its agility, precision, and collaborative spirit, transforms our partnerships.

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Clinical Trials Clinical Research Trials Compliance 75

Olympian Clinical Research

JUNE 27, 2023

Keeping a Food Journal: Document your meals and any corresponding skin changes to identify trigger foods. Engage in Adult Eczema Clinical Research with Olympian Clinical Research Seek additional assistance for your adult eczema by participating in a clinical research study at Olympian Clinical Research.

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Clinical Research Packaging Doctors Production 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. Everyone may use different software systems to manage these documents.

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Clinical Trials Trials Compliance Clinical Research 52

PPD

OCTOBER 8, 2024

The PPD™ clinical research business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent white paper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”

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Trials Clinical Trials Clinical Development Clinical Research 98

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. Study sponsors need quality results as quickly as possible to maximize profit-generation opportunities in the market.

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Clinical Trials Trials Clinical Research FDA 98

PPD

AUGUST 14, 2024

According to research commissioned by the PPD clinical research business of Thermo Fisher Scientific, 55% of respondents reported patient recruitment in clinical trials as the top challenge facing their organization, followed closely by increasing trial complexity.

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Clinical Trials Trials Clinical Research Research 92

Olympian Clinical Research

APRIL 28, 2021

It’s not uncommon for fibromyalgia to co-exist with conditions like IBS, chronic fatigue syndrome, migraines, interstitial cystitis, or even anxiety and depression, so it’s important for patients to document all of their symptoms and share that information with their doctor before determining a treatment plan. .

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Clinical Research Clinical Trials Treatment Doctors 52

PPD

OCTOBER 21, 2024

A provider of CRO services like the PPD clinical research business of Thermo Fisher Scientific has the FSP capabilities and expertise to quickly and efficiently support clinical development functions for a biotech developer.

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International Clinical Development Clinical Trials Clinical Research 87

Advarra

OCTOBER 31, 2023

A common misconception in the manufacturing and research development landscape is quality systems can be bought off the shelf and there are no significant differences among the proliferation of quality systems. Clinical research is grounded in scientific integrity, participant safety, and data reliability.

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Compliance Clinical Research Clinical Trials Trials 52

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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Clinical Trials Clinical Research Trials Research 52

Advarra

MAY 25, 2022

Compliant, efficient document management during the various phases of a clinical trial is essential. As clinical research continues to move towards a remote environment, centralizing and integrating your regulatory management process and technology is vital to your institution’s success. Current eReg Integrations.

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Clinical Trials Compliance Trials Research 52

Advarra

FEBRUARY 13, 2024

Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security measurements to protect their data and stay compliant. Having SSO available via cellular device enables easy and secure access to research systems.

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Compliance Clinical Research International Research 52

Advarra

SEPTEMBER 30, 2022

Is the clinical research industry winning or failing at innovation? Despite the fast pace of medical innovation, the lack of consistency between technology systems managing these advancements ultimately inhibits research progress. . Has innovation really succeeded in clinical research if this is the state we’re currently in?

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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. Engaging with regulatory agencies early and continuously is essential.

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PPD

AUGUST 7, 2024

Agents can document these events accurately and forward the information to the appropriate individuals, such as Principal Investigators or pharmacovigilance teams. Prompt reporting and monitoring of these events are essential for participant safety and the integrity of the trial data.

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Clinical Trials Trials Compliance Clinical Research 97

Advarra

NOVEMBER 9, 2023

Document Management Effective document management is a core component of QMS. A successful QMS ensures study-related documents, such as the protocol, informed consent forms, and investigator brochures, are created in a controlled and standardized manner. This guarantees consistency and compliance.

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Clinical Trials Compliance Trials Clinical Research 52

Advarra

OCTOBER 6, 2022

Whether they’re recorded on paper or electronically, source data should follow ALCOA-C, an acronym used in clinical research for: . If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective. . Attributable . Contemporaneous . Original . Accurate .

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Compliance Clinical Trials Trials Clinical Research 52

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Trials Compliance FDA 40

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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Licensing Licensing Pharmacy FDA 52

Advarra

FEBRUARY 14, 2024

Document Exchange If a site has an electronic investigator site file (eISF) or another document management system, consider interfacing rather than requiring an entirely new system. Training Accepting training from your organization from one study to the next on general research requirements can go a long way.

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