ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

Pharmacy 59

Pharmacy Trials Clinical Trials Clinical Trials 59

ACRP blog

NOVEMBER 8, 2023

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Clinical Research 111

pharmaphorum

MAY 20, 2022

In recent years the retail pharmacy chain has begun to delve more and more deeply into the healthcare sector – by constantly expanding the basic healthcare services offered at their instore Minute Clinics, and by buying into the health insurance insurance space with their $69 billion purchase of Aetna in 2017. JR: Let’s flip it.

Clinical Trials 90

Clinical Trials Clinical Trials Trials Clinical Research 90

ACRP blog

FEBRUARY 15, 2023

By that time, I believe studies with adequately diverse patient groups will receive priority review from regulators, while those lacking diversity will be sent back to the drawing board, with a requirement for more research, such as post-marketing commitments. However, it may take five or more years for this approach to scale.

Clinical Trials 102

Clinical Trials Clinical Trials Trials Clinical Research 102

Pharmaceutical Technology

SEPTEMBER 10, 2008

was established in 1999 in the process of privatisation of the State Research Institute for Pharmacy and Biochemistry in the Czech Republic. Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. .” Dr Ivana Surovà: Biotest s.r.o.

In-Vitro 100

In-Vitro Genotoxicity In-Vivo Development 100

ACRP blog

JANUARY 31, 2023

As Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, Chief Integration Officer with Centricity Research, settles into her volunteer duties as the 2023 Chair of the Association Board of Trustees (ABoT) for ACRP, she took time to answer some questions about her outlook on the current state of the Association and the clinical research enterprise.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

MAY 10, 2023

Eunjoo Pacifici, PharmD, PhD, describes her work educating students to be the next generation of clinical research professionals. Pacifici is Chair of the Department of Regulatory and Quality Sciences and Associate Professor of Regulatory and Quality Sciences at USC School of Pharmacy.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

APRIL 24, 2023

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

pharmaphorum

DECEMBER 21, 2021

There has been progress in this area in recent years, with both the European Union (EU), through Regulation (EC) No 1901/2006 , and the US, through the Orphan Drug Act , enacting legislation to encourage the development of therapies for Rare Diseases. Headway being made. The potential to leverage genomic data.

Development 98

Development Genome Genomics Drugs 98

Advarra

APRIL 30, 2024

In some countries, local regulations may indicate the sub-investigators need to sign as well. Pharmacy File Ensure inventory records are up to date. Determine if there is a separate delegation log in pharmacy or included in ISF. pharmacy), reference should be made to where the documentation is kept.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

pharmaphorum

JANUARY 27, 2021

Examples like this should be used to reassure people that things are done differently now and to raise awareness of how regulations and standards are evolving. One ‘customer’ in the pharmacy says, “I didn’t realize everything needed to be tested.” Increase awareness and understanding.

Research 52

Research Clinical Trials Clinical Trials Vaccination 52

XTalks

MARCH 7, 2023

Pegcetacoplan Trial Results Syfovre is a C3 therapy designed to regulate the over activation of the complement cascade. In a company presentation, Apellis revealed the list price of Syfovre to be $2,190 per vial before discounts and said it would be made available through specialty distributors and pharmacies across the US.

FDA Approval 98

FDA Approval Drugs Sales Trials 98

pharmaphorum

JUNE 30, 2022

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally. Patient access.

Trials 64

Trials Development Drugs Clinical Trials 64

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Ancillary services are also needed, such as a pharmacy to store, prepare and deliver the IP and labs such as a CSF lab to prepare samples.”.

Trials 83

Trials Drug Delivery Drugs Gene 83

The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If

Clinical Development 52

Clinical Development Development Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. Persons”, as such term is defined in Regulations under the U.S.

Drugs 52

Drugs Containment Development Clinical Development 52

pharmaphorum

SEPTEMBER 1, 2020

The 21st century pharmaceutical and biotech sector has come a long way from its roots in 19th century pharmacy. Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids.

Medicine 145

Medicine Insulin Drugs Pharmacy 145

pharmaphorum

MARCH 3, 2022

From Brexit and COVID-19 to the wholescale shift in the way research is designed, conducted, and reported, the UK’s clinical trials sector has faced a raft of challenges in recent years. We have had lots of challenges, particularly in the non-COVID space,” said Jennifer Harris, Director of Research Policy at the ABPI. “We

Research 98

Research Clinical Research Clinical Trials Clinical Trials 98

pharmaphorum

DECEMBER 15, 2022

For health innovation, digital transformation in the NHS – using digital technology to change and improve services and outcomes for patients, including primary care records, legacy items, and clinical research – is critical. One such example is the online pharmacy concept, like Pharmacy2U, with its 1.5

Life Science 97

Life Science Medicine Clinical Trials Clinical Trials 97

ACRP blog

JANUARY 6, 2025

Department of Justice (DOJ) continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity in the U.S.

Compliance 69

Compliance Clinical Trials Clinical Trials Clinical Research 69

XTalks

SEPTEMBER 14, 2020

Meanwhile, N95 masks are in such short supply that regulators have told healthcare workers they can be used multiple times with little evidence that disinfecting them works. Below are some free webinars you can register for that have delved into the topic: Continuing Clinical Research Innovations After COVID-19.

Vaccine 92

Vaccine Vaccination Antibody Life Science 92