PPD

JULY 29, 2024

The benefits of utilizing AI in clinical research Patient recruitment and diversity AI is increasingly being utilized in the recruitment process for clinical trials , aiming to connect individuals with potential benefits from investigational treatments.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

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.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 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.

Trials 80

Trials Clinical Trials Regulations FDA 80

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.

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

The Pharma Data

DECEMBER 23, 2020

BioMedion AG – Germany-based BioMedion acquired the Compliance Division of arivis AG, a provider of regulatory software and biomedical 3D and big image data software solutions. Following the acquisition, the arivis5D content platform will be rebranded to neuronOS. GeneMe – Based in Poland, GeneMe completed a €5.2 million seed funding round.

Licensing 52

Licensing Licensing Vaccine Trials 52

Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. This minimizes the variability in data when a study goes hybrid and improves compliance and quality of data.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

FDA 40

FDA Science Clinical Trials Production 40