Drug Discovery World

NOVEMBER 14, 2022

In 2021, in the document Saving and Improving Lives: The Future of UK Clinical Research Delivery the UK Government set out an ambition to create a world-leading UK clinical research environment that is more efficient, more effective and more resilient. .

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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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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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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

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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Agency IQ

AUGUST 30, 2024

many types of clinical research must comply with regulations intended to protect the rights of research participants. The FDA revised its guidance on informed consent in 2023 – the first update to the document to be finalized since 1998. What’s next? The meeting will be held October 30, 2024.

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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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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

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

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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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

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

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

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

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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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 Doctors Treatment 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

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 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

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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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

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 FDA 52

Advarra

OCTOBER 19, 2023

The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Each of these have contributed to a rapidly evolving clinical research landscape.

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Clinical Trials Trials Clinical Research Research 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

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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Drug Discovery World

OCTOBER 12, 2022

10-15 years ago, there were few validated medical devices for clinical research, and now we have a lot of technology to choose from. The foremost consideration when choosing sensor technology is to ensure that it is fit-for-purpose and will provide the clinical evidence required for the study. About the author .

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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

Advarra

JANUARY 10, 2024

There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data collection. However, adopting eSource is challenging for many research facilities. Research sites may elect to collect data using eSource, paper source, or a combination of the two.

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Regulations Research Clinical Research Compliance 52

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

Agency IQ

APRIL 12, 2024

In 2021, the ICH followed this up with a draft principles document on the E6 update. In March 2023, ICH announced a forthcoming addendum to the still-under-development new E6(R3) document, Annex 2. The bulk of the document is still content in Annex 1 (best practices and general guidelines).

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Agency IQ

AUGUST 11, 2023

Quick background: Optical Character Recognition (OCR) technology systems convert physical, printed, or scanned documents into machine-readable text, as defined by IBM. These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more. What’s next?

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FDA Compliance Clinical Trials Pharmacokinetics 40

Vial

MAY 8, 2024

A Brief Introduction Medrio was founded in 2005 with the mission to revolutionize clinical research with the creation of the first cloud-based EDC system, designed to simplify data collection without requiring advanced programming skills. Established in 2020, Vial has rapidly emerged as a leading technology-driven CRO.

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Clinical Trials Trials Clinical Research Laboratories 52

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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Clinical Trials Research Trials Clinical Research 52

Vial

FEBRUARY 21, 2024

These companies are equipped with the expertise and resources to lead successful medical device clinical trials. Medical device sponsors often seek out CROs so they can outsource services such as clinical research, site selection, trial design, and regulatory consulting.

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Clinical Trials Trials Compliance Regulations 52

Advarra

JANUARY 10, 2023

As the clinical research industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. Clinical research staff time is incredibly valuable, and team members are constantly juggling multiple tasks at any given time. eConsent Gives Sites Flexibility.

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Clinical Trials Clinical Research Trials Research 52

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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Drug Discovery World

DECEMBER 8, 2023

The need for cell and gene therapy development standardisation Presently, a total of 3,866 cell and gene therapies are in various stages of development , spanning from pre-clinical research to pre-registration phases.

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