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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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

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

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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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

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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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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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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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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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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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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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

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

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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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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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

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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Trials Clinical Trials Regulations FDA 80

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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Trials Nurses FDA Clinical Trials 52

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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Compliance Clinical Trials Trials 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

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. This all starts with a well-designed clinical protocol, in addition to trial plans and documents aiding in protocol execution.

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Clinical Trials Trials Clinical Research International 52

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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Clinical Trials Trials Clinical Research Disease 59

Advarra

DECEMBER 1, 2022

The sIRB compliance date for cooperative research went into effect on January 20, 2020, and requires single IRB review for virtually all federally funded multisite research. A document exchange platform is designed to support and streamline the sIRB process for the sIRB and relying institutions alike. FDA Initiatives.

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Regulations Compliance FDA Clinical Trials 52

PPD

APRIL 30, 2024

Lessons learned & challenges Changing country and regional requirements Despite the EU CTR’s promise of harmonization, conflict of country/site documentation requirements are still visible between the European Medicines Agency (EMA) and member states.

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Clinical Trials Regulations Trials Pharmaceutical Companies 52

Advarra

AUGUST 18, 2022

In the last few years, the clinical research industry has seen a bigger push for electronic informed consent (eConsent) than ever before. Obtain and document informed consent. eConsent can include something as small as research staff collecting an eSignature via PDF, or as large as using a comprehensive eConsent platform.

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Research FDA Clinical Research Compliance 52

Advarra

JANUARY 18, 2024

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Documents like signed informed consent forms (ICFs) indicate active recruitment activities.

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Clinical Trials Trials Compliance Clinical Research 52

Advarra

JUNE 16, 2022

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. Budget negotiation .

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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Drug Development Disease Clinical Trials Drugs 52

Advarra

DECEMBER 1, 2022

HIPAA statements are typically provided to participants in one of two ways: Standalone document in addition to the ICF. For clinical research, this may include local researchers sharing the information with a third party, or, in the case of a partial waiver of Authorization, reviewing PHI for recruitment purposes.

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Clinical Trials Trials Regulations Research 52

Olympian Clinical Research

NOVEMBER 6, 2023

Smoking: Cigarette smoking is a well-documented trigger and worsening factor for HS. Contribute to Hidradenitis Suppurativa Breakthroughs At Olympian Clinical Research, we’re passionate about making a difference for those with HS. You can contribute to this essential work by participating in our clinical trials.

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Clinical Trials Doctors Clinical Research Treatment 52

Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. In cases regarding compliance, even though organizations have a system to allow data capture, it doesn’t fulfill the needs and requirements for research trials.

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Compliance Clinical Research Trials Research 52

Crucial Data Solutions

MARCH 30, 2023

With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. EDC, as can be ascertained from the name, involves collecting clinical research data electronically or digitally. Yet, this is not the case.

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Clinical Trials Trials Clinical Research Research 52

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.

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