FDA approves IND for clinical trial evaluating CBD-based drug

Outsourcing Pharma

Clinical DevelopmentThe agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials.

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Europe launches initiative to transform clinical trials

BioPharma Reporter

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system. Clinical Development

Healthcare ‘heroes’ make decentralized clinical trials possible

Outsourcing Pharma

Clinical DevelopmentA physician assistant from Hawthorne Effect shares how she and other trained health professionals contribute their knowledge and talents to in-home studies.

CVS Health broadens commitment to improving clinical trial infrastructure

Outsourcing Pharma

The owner of the pharmacy giant has announced plans to partner with various stakeholders in an effort to effect improvements across the trial ecosystem. Clinical Development

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

XTalks

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. Full-Service Clinical Development.

Curebase to partner on VR-based chronic pain clinical trials

Outsourcing Pharma

The decentralized trial tech firm will work with Applied VR on five studies testing the viability of virtual-reality therapy in treating pain patients. Clinical Development

Medicenna takes on deadly brain cancer in clinical trial

Outsourcing Pharma

The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer. Clinical Development

PRA partners on acute leukemia clinical trial

Outsourcing Pharma

The CRO will work with the Leukemia and Lymphoma Society on a global master clinical trial to explore treatments for pediatric acute leukemia. Clinical Development

Increasing patient engagement with UK clinical trials

Pharma Phorum

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. How the NIHR’s Patient Engagement in Clinical Development service can help.

The right tech can add real-world context to clinical trials: Sharecare

Outsourcing Pharma

Clinical DevelopmentAccording to a leader from the health engagement solutions firm, intelligent use of technology tools can add patient-centricity and realism to a study.

Mobile optometry service expands clinical trial support

Outsourcing Pharma

Clinical DevelopmentThanks in part to the recent completion of an $8m investment, 2020 On-site plans to expand its services, including the mobile support of vision research.

Now what? The future of clinical trials after the pandemic

Pharma Phorum

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. This challenge has led to significant delays in clinical studies, with a 40% increase in data cleaning cycle times over the last two years.

Clinical trials have ‘much work to do’ in boosting diversity

Outsourcing Pharma

Clinical DevelopmentA veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short.

Scottish biotech outfit launches clinical trials division

Outsourcing Pharma

Intelligent Tissue Group has launched its Intelligent Clinical trials facility to help assess the effectiveness and safety of potential new treatments. Clinical Development

Clinical Trials Day 2021: Reflecting on a Challenging Year That’s Made the Industry Stronger

XTalks

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Clinical Trials Day 2021: The Year of COVID-19. COVID-19 Challenges for Clinical Researchers. Clinical Trial Technology.

Elligo: clinical trials can learn from healthcare

Outsourcing Pharma

Clinical DevelopmentDuring the CRAACO conference, a leader from the study solutions firm will discuss how researchers can learn and benefit from the other industry.

Biohaven wraps patient enrollment for ALS clinical trial arm

Outsourcing Pharma

Clinical DevelopmentThe pharma company has completed enrollment of amyotrophic lateral sclerosis patients in its study investigating drugs like verdiperstat, an oral treatment.

Sharp introduces clinical trial IMS

Outsourcing Pharma

The Clinventory inventory management system is designed to help study sponsors streamline management of their clinical trial inventory and supplies. Clinical Development

Clinical trial volume, variety drive data solutions

Outsourcing Pharma

eClinical, a provider of clinical data service solutions, has seen an increase in interest in clinical data platform and other digital products. Clinical Development

Dive into the digital evolution of clinical trials

Outsourcing Pharma

Taking place December 9, the Digital Advances in Clinical Trials webinar covers notable advances in clinical trial technology, and the future of the field. Clinical Development

Saama, Oracle partner on integrated clinical trial technology

Outsourcing Pharma

Saamaâs range of Smart applications will be integrated with the Oracle Health Sciences Clinical One platform to help users accelerate drug development. Clinical Development

Digital experience impacts clinical trial success: Medallia

Outsourcing Pharma

Clinical DevelopmentA representative from the digital experience management firm discusses how improving the quality of tech interactions with patients can elevate results.

Paige, Perspectum forge AI-centered clinical trial alliance

Outsourcing Pharma

The digital pathology firm and image-analysis software developer will partner on artificial intelligence based solutions to improve trial decision making. Clinical Development

Increased representation benefits cancer clinical trials: Science 37

Outsourcing Pharma

Clinical DevelopmentAn expert from the decentralized study solutions company shares perspectives on the importance of inclusivity and solutions that could improve representation.

Reify Health raises $30m for clinical trial tech

Outsourcing Pharma

The cloud-based study technology firm has secured Series B funding to help develop and promote products like its clinical trial platform, StudyTeam. Clinical Development

Statistical innovation could elevate global clinical trials: Cytel

Outsourcing Pharma

The trial tech firm says analysis of trials in low- and middle-income regions reveals that innovative statistical methods could make a huge difference. Clinical Development

WHO issues position statement on TB clinical trial design

Outsourcing Pharma

The World Health Organization hopes to encourage the development of novel therapies for tuberculosis by spotlighting key clinical study characteristics. Clinical Development

New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

BioPharma Reporter

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials. million from Canada’s National Research Council (NRC) to support the clinical advancement of bacTRL-Spike.

SCOPE 2021 to take on tough clinical trial challenges

Outsourcing Pharma

The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics. Clinical Development

The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

CATO Research

Hence, the next clinical milestone will very likely be the development of allogeneic CART therapies that could offer off-the-shelf products with immediate availability as an on-demand therapeutic option for patients with high unmet medical needs. Meeting Clinical Objectives.

Use of medical imaging in clinical trials expanding

Outsourcing Pharma

Clinical DevelopmentWhile the technology has been found mostly in dermatological applications, its use in studies is expanding, according to Illingworth Research Group.

Sponsors must rethink ‘primitive’ clinical trial approaches: Phesi

Outsourcing Pharma

A leader from the clinical development services provider recommends using industry modal values to avoid protocol amendments, enrollment problems and more. Clinical Development

‘We need to change the current clinical trial infrastructure’: Medable

Outsourcing Pharma

Clinical DevelopmentThe companyâs new chief scientific officer, a 30-year industry veteran, shares her informed thoughts on the future direction of the research field.

The evolution of clinical trials: the pharmaphorum podcast

Pharma Phorum

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern.

PRA ‘toolkit’ pinpoints rare-disease clinical trial risks

Outsourcing Pharma

The free Patient-Centric Trial Development Toolkit is aimed toward helping sites and sponsors identify and minimize risks in rare-disease clinical studies. Clinical Development

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments

BioTech 365

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.Validive® Phase 2b/3 VOICE Trial Cleared … Continue reading → GlobeNewswire

Increasing patient engagement with UK clinical trials

Pharma Phorum

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Designing better trials.

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. South Africa Phase 2b trial update. Mexico pivotal Phase 3 trial update.

Elligo, Cerner join to expand clinical trial reach in communities

Outsourcing Pharma

Clinical DevelopmentThe two firms will work together to broaden the technology, tools, and resources available to hospitals and practices in less-accessible communities.

Multi-national studies call for informed approach: Firma Clinical Research

Outsourcing Pharma

Am expert from the CRO discusses unique challenges associated with running clinical trials that stretch across national boarders and how to conquer them. Clinical Development

Pfizer begins clinical trials of COVID-19 antiviral pill

Pharma Phorum

Pfizer has begun clinical development of an antiviral pill against COVID-19, which could be prescribed to patients at the first sign of infection. The post Pfizer begins clinical trials of COVID-19 antiviral pill appeared first on.