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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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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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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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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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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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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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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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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On Medicine

FEBRUARY 8, 2024

In previous research by members of the CHARMER team, older people and their carers told us that they would like their medicines reviewed by doctors during their hospital stay. We have five public and patient involvement members working on the study, with their focus on providing input into patient-facing documents and processes.

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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. Informed consent is one of the three foundational protections for research involving human subjects. However, HHS’ regulations only apply to research that is directly conducted or supported by the U.S.

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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. associates, residents, research fellows). based sites.

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Advarra

NOVEMBER 9, 2023

Efficient and compliant study startup activities set the foundation for the entire research process. This blog explores the pivotal role QMS plays in study startup activities as well as how a right-sized QMS contributes to the overall success of clinical trials. This guarantees consistency and compliance.

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Advarra

FEBRUARY 14, 2024

However, each site is different, and sponsors and contract research organization (CRO) study teams must continually evaluate how they engage uniquely with each sites and find ways to make collaboration and workflows more efficient. Amendments With protocol amendments, staff will need to update and resign documents.

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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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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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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

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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Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. Using eSource Instead of Paper Designed to help sites accomplish necessary data capture activities and workflows, eSource enables research staff to capture all necessary information for both research and standard-of-care purposes.

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PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. The PPD clinical research business of Thermo Fisher Scientific’s suite of clinical trial contact center solutions keeps your trial moving while creating the foundations for lasting relationships.

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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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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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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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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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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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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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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

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

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. About This List .

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Vial

FEBRUARY 21, 2024

However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products. This is where contract research organizations (CROs) come into play.

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Vial

MAY 8, 2024

These systems are often used by contract research organizations (CROs) facilitate the collection, verification, and management of electronic data from various sources, including electronic medical records (EMRs), laboratory systems, and electronic patient-reported outcomes (ePROs).

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In 2021, the ICH followed this up with a draft principles document on the E6 update.

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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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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.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Advarra

APRIL 25, 2024

The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational change. Technology continues to advance clinical operations, and organizations must proactively adapt. How can your organization stay on top of it all?

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