Medical research

ACRO Releases Toolkit to Help Advance Decentralized Clinical Trials

Thursday, July 29, 2021 - 11:00am

At the same time, they understandably express concern about the quality and integrity of the data as trials are decentralized.

Key Points: 
  • At the same time, they understandably express concern about the quality and integrity of the data as trials are decentralized.
  • With the DCT Data Flow Maps project, ACROs Decentralized Clinical Trials Working Party aims to provide transparency and clarity on the processes for keeping data secure, confidential, and accurate, said Jackie Kent, Chief Customer Officer at Medidata and Vice-Chair of the ACRO Board of Directors.
  • The Association of Clinical Research Organizations (ACRO) represents clinical research and technology companies that provide a variety of specialized services to support the development of new pharmaceuticals, biologics, and medical devices.
  • ACRO member companies operate in more than 100 countries across the globe and conduct or support the conduct of the majority of clinical trials worldwide.

Satsuma Pharmaceuticals Announces First Subject Randomized in SUMMIT™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine

Wednesday, July 28, 2021 - 9:05pm

(Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.

Key Points: 
  • (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.
  • The SUMMIT study was designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018.
  • For further information regarding the STS101 SUMMIT Phase 3 efficacy trial, see www.ClinicalTrials.gov, identifier NCT04940390: A Randomized, Double-Blind, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT).
  • Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine.

COVID-19 Vaccine Development Tools Market Research Report 2021 - ResearchAndMarkets.com

Wednesday, July 28, 2021 - 4:07pm

The "COVID-19 Vaccine Development Tools Market Size, Share & Trends Analysis Report by Technology, by Application (Vaccine Process Development, Vaccine Research), by End Use (CROs, Pharma & Biopharma Companies), and Segment Forecasts, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "COVID-19 Vaccine Development Tools Market Size, Share & Trends Analysis Report by Technology, by Application (Vaccine Process Development, Vaccine Research), by End Use (CROs, Pharma & Biopharma Companies), and Segment Forecasts, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • The market is expected to expand at a CAGR of 8.6% from 2021 to 2028.
  • Research professionals across the globe, are rapidly persuading the identification and development of viable candidates to develop COVID-19 immunization shots.
  • The tools are also pooled under the umbrella mechanism, namely, the COVAX Facility to ensure effective procurement as well as equitable access to, COVID-19 vaccination and development tools.

THREAD and Almac Clinical Technologies Partner to Eliminate Common Clinical Trial Delays

Wednesday, July 28, 2021 - 1:01pm

THREAD , a technology and service provider enabling decentralized clinical trials (DCTs), and Almac Clinical Technologies , a member of the contract and development organization, Almac Group , today announced a strategic partnership.

Key Points: 
  • THREAD , a technology and service provider enabling decentralized clinical trials (DCTs), and Almac Clinical Technologies , a member of the contract and development organization, Almac Group , today announced a strategic partnership.
  • Almacs IXRS solution and industry-leading services for randomization and clinical trial supply management will be available to THREAD customers and THREADs DCT solution will be available to Almac customers.
  • Were thrilled to be working with THREAD, an acknowledged leader in DCT technology, said George Tiger, vice president of Global Business Development, Almac Clinical Technologies.
  • Our solutions facilitate more than simplifying patient and trial material management they engineer quality into the clinical trial process.

CASTOR Launches Scalable Patient Enrollment and eConsent Platform to Increase Patient Access and Reduce Recruitment Timelines

Wednesday, July 28, 2021 - 12:58pm

Castor , a leading provider of clinical trial technology to democratize clinical research, today announced a full patient onboarding experience to enhance patient enrollment, from recruitment to first study visit.

Key Points: 
  • Castor , a leading provider of clinical trial technology to democratize clinical research, today announced a full patient onboarding experience to enhance patient enrollment, from recruitment to first study visit.
  • Building on Castors eConsent solution , patients can now experience a seamless transition on their journey from recruitment to screening, consent, and enrollment.
  • We have seen by simplifying participant enrollment, our study sponsors are seeing improved retention in trials and reduced recruitment timelines, said Derk Arts, Ph.D., M.D., CEO & Founder, Castor.
  • To Learn More -- Register to Castor & Lightships webinar : Its a matter of choice: Hybrid eConsent for On-Site or Remote Patient Enrollment.

Global Academic Research Organization UCL Selects Phlexglobal's Innovative eTMF Solution to Enhance TMF Compliance and Inspection-Readiness Across Entire Study Portfolio

Wednesday, July 28, 2021 - 12:00pm

PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe.

Key Points: 
  • PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe.
  • The decision by the UCL team followed a comprehensive tendering process with Phlexglobal appointed as the preferred bidder to help UCL streamline TMF management and oversight while reducing cost and risk.
  • "We're honored that a highly respected research organization like UCL selected Phlexglobal for their eTMF solution," said John McNeill, Chief Executive Officer of Phlexglobal.
  • The Institute of Clinical Trials and Methodology at UCL is a centre of excellence for clinical trials, meta analysis and epidemiological studies.

Dyadic Announces Technology Transfer and Licensing Agreement With South Africa’s Rubic Consortium Aiming to Develop and Commercialize Vaccines for Distribution Throughout the African Continent

Tuesday, July 27, 2021 - 1:20pm

Rubic was founded by a consortium of public health, medical, academia, vaccine technology, technology transfer and economic sector experts interested in addressing the regions specific challenges related to vaccine availability and affordability.

Key Points: 
  • Rubic was founded by a consortium of public health, medical, academia, vaccine technology, technology transfer and economic sector experts interested in addressing the regions specific challenges related to vaccine availability and affordability.
  • Establishing a vaccine manufacturing unit with the infrastructure, processing operations and capabilities for the manufacture and distribution of high-quality vaccines throughout the African continent.
  • Dyadic will facilitate technology transfer of the C1 Platform to Rubic through the completion of clinical trials.
  • The Rubic Consortium is made up of promoters of the project representing public health, medical, academia, vaccine technology, technology transfer and economics sectors.

Optimi Health Strengthens Clinical and Regulatory Expertise

Tuesday, July 27, 2021 - 2:00pm

Mr. Simon stated, Working on the Optimi project is an exciting opportunity to help people with unmet medical needs.

Key Points: 
  • Mr. Simon stated, Working on the Optimi project is an exciting opportunity to help people with unmet medical needs.
  • The IMPACT team is aiming for a clinical trial that meets international standards and this is the sort of goal I find compelling.
  • His clinical trial experience includes advanced studies for therapeutic cancer vaccines, as well as numerous projects supporting clinical trials for drugs, natural health products and medical devices.
  • The IMPACT program provides Optimi expert clinical support towards commercializing proposed psilocybin-based formulations through the conduct of clinical trials and expert assistance towards securing regulatory approval.

Patients Rate their Clinical Trial Experience Positively, but Trial Locations Still Pose Barriers to Enrollment

Tuesday, July 27, 2021 - 2:00pm

Our study found that individuals are generally pleased with their clinical trial experience, but organizers could benefit from working more closely with physicians and being strategic about trial locations to boost enrollment and increase accessibility.

Key Points: 
  • Our study found that individuals are generally pleased with their clinical trial experience, but organizers could benefit from working more closely with physicians and being strategic about trial locations to boost enrollment and increase accessibility.
  • Considering the patient experience in the design of clinical trials is essential, said Pam Cusick, Senior Vice President of Rare Patient Voice.
  • Even though personal physicians may not be directly involved in ongoing clinical trials, they do drive the majority of patient enrollment.
  • According to the survey, nearly half (48%) of respondents who had participated in a clinical trial found out about the trial through their physician.

Half of U.S. parents may not vaccinate their youngest child against Covid-19

Tuesday, July 27, 2021 - 8:40pm

Among all U.S. parents surveyed, only 49 percent reported planning to vaccinate their youngest child when a Covid-19 vaccine is approved for children, while 26 percent of parents said they Awere unsure and 25 percent said they will not vaccinate their child.

Key Points: 
  • Among all U.S. parents surveyed, only 49 percent reported planning to vaccinate their youngest child when a Covid-19 vaccine is approved for children, while 26 percent of parents said they Awere unsure and 25 percent said they will not vaccinate their child.
  • In contrast, a higher proportion of parents in NYC (62 percent) reported planning to vaccinate their youngest child against Covid-19, while 15 percent were unsure and 23 percent did not plan to vaccinate.
  • Also in NYC, non-Hispanic Black parents were less likely to report plans to vaccinate their children for Covid-19 compared to other race/ethnicity groups.
  • In both surveys, female parents were less likely to report plans to vaccinate their children.