PPD

OCTOBER 8, 2024

With FSO, all clinical trial tasks (e.g., In a hybrid model, one or more FSP offerings are added to a new or existing FSO arrangement to optimize clinical trial operations or address unforeseen circumstances and changing demands. study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.)

Trials 98

Trials Clinical Trials Clinical Development Clinical Research 98

Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Many of these patients’ conditions are disabling.

Trials 58

Trials Clinical Trials Therapies Drug Development 58

Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

PPD

DECEMBER 19, 2023

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Read our white paper to learn the keys to successfully implementing functional service partnerships.

International 52

International Research Drug Development Pharmaceuticals 52

Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions.

Science 40

Science Regulations International FDA 40