Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.

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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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Drug Discovery World

JUNE 20, 2024

Now, you might wonder: how exactly can these advanced artificial intelligence models propel clinical research forward? In the context of clinical trials, these models can help us add context to insights. Conventional AI models allow us to extract insights from the clinical data but they do lack context.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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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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Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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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.

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PPD

SEPTEMBER 6, 2023

Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?

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Advarra

JUNE 14, 2022

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Annual reports to confirm ongoing compliance and maintain accreditation. Compliance with Applicable Regulations. Compliance with Other Requirements. IRB Clients.

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Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

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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. Fortunately, leading global regulators have launched key initiatives.

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. Consequently, this strategy substantially reduces the failure rate of cancer clinical trials. Data is not the only challenge we have in this journey.

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Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

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Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations.

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Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. Keeping abreast of changes in regulatory frameworks guarantees compliance and minimizes regulatory-related delays.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Exemptions: Despite its overarching reach, the proposal does carve out exemptions.

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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

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PPD

AUGUST 9, 2023

Harmonized Clinical Trial Data Structures to Drive Innovation within Decentralized Clinical Trial Models Data is the fuel of the digital enterprise — it is the lifeblood needed to execute key processes, make decisions and achieve regulatory compliance. This said, there is regulatory uncertainty that must be resolved.

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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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Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 To learn about the history of these trial technologies and their adoption within the clinical research industry, read more here !

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PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. For rapid expansion of late-stage assay platforms, speed and a proven track record are pivotal.

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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. The data needed for analysis takes months to collect and has a high cost.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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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. Regulations emphasize the need for accurate and controlled record-keeping to ensure trustworthy data.

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Advarra

NOVEMBER 17, 2022

Today, many clinicians and researchers acknowledge giving children drugs with no supporting pediatric research data and adjusting dosing based on weight likely isn’t the most effective way to treat them. The ethical way forward is to offer children [1] better opportunities to participate in clinical research.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating From going to clinic visits and arranging a friend or caregiver to take you to the drive itself and self-care preparation, it’s truly a horrible position to be in. 

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Agency IQ

AUGUST 11, 2023

The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management. These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

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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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The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. “With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades.

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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

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The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. Specifically, wholesalers should conduct in-depth audits to verify full compliance with EU GDP requirements.

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The Pharma Data

NOVEMBER 10, 2020

However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Additionally, oral capsules provide the convenience of home use, and increase patient compliance by eliminating the need for infusions in a clinic or hospital setting. NEW YORK and LONDON, Nov.

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PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. In three years of tracking safety reporting compliance with this client, their annual China EC Compliance rates averaged over 99%.

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