Medical protocol

eDeviation the New Protocol Deviations Cloud Software Solution

Retrieved on: 
Tuesday, April 20, 2021

"In a context of increasingly complex clinical trials, we are proud to offer a solution that will help sponsors, CROs and EC/IRB minimize the risks associated with protocol deviations.

Key Points: 
  • "In a context of increasingly complex clinical trials, we are proud to offer a solution that will help sponsors, CROs and EC/IRB minimize the risks associated with protocol deviations.
  • "\nA protocol deviation is any change, divergence, or departure from the study design or procedures defined in the approved protocol, consent document, recruitment process, or study materials (e.g.
  • "Protocol deviation" is a general term encompassing protocol exceptions, changes made to avoid immediateharm to subjects, and protocol violations.
  • Protocol deviations can be either major or minor according to the impact of the deviation on patientsafety and data integrity.\neDeviation is aProtocol Deviations and Violations management cloud software designed to collect, manageand reviewprotocol deviations in a simple, effective, and GxP-compliant way.\n'

Biorasi Commended by Frost & Sullivan for its Full-service Offering to Drive Rare Disease Patient Recruitment for CROs

Retrieved on: 
Tuesday, September 22, 2020

Biorasi's milestone-based, patient-centric approach to driving patient recruitment for rare diseases, hard-to-recruit indications, and clinical trial rescues differentiate it from its peers.

Key Points: 
  • Biorasi's milestone-based, patient-centric approach to driving patient recruitment for rare diseases, hard-to-recruit indications, and clinical trial rescues differentiate it from its peers.
  • "Powered by its proprietary Talos trial management system, Biorasi advances technology-enabled protocol optimization programs, improving clinical trial performance, and success rates.
  • Beyond solving patient recruitment and engagement challenges, Biorasi addresses issues related to protocol design, clinics, and delays due to new regulations.
  • Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in devising a strong growth strategy and robustly implementing it.

Biorasi Commended by Frost & Sullivan for its Full-service Offering to Drive Rare Disease Patient Recruitment for CROs

Retrieved on: 
Tuesday, September 22, 2020

Biorasi's milestone-based, patient-centric approach to driving patient recruitment for rare diseases, hard-to-recruit indications, and clinical trial rescues differentiate it from its peers.

Key Points: 
  • Biorasi's milestone-based, patient-centric approach to driving patient recruitment for rare diseases, hard-to-recruit indications, and clinical trial rescues differentiate it from its peers.
  • "Powered by its proprietary Talos trial management system, Biorasi advances technology-enabled protocol optimization programs, improving clinical trial performance, and success rates.
  • Beyond solving patient recruitment and engagement challenges, Biorasi addresses issues related to protocol design, clinics, and delays due to new regulations.
  • Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in devising a strong growth strategy and robustly implementing it.

Pharm-Olam Launches New Protocol Optimization Service

Retrieved on: 
Tuesday, June 16, 2020

The Protocol Optimization Service will benchmark a sponsors study design against other similar clinical trials and identify optimization opportunities for consideration and inclusion.

Key Points: 
  • The Protocol Optimization Service will benchmark a sponsors study design against other similar clinical trials and identify optimization opportunities for consideration and inclusion.
  • Protocol optimization also provides a tool to effectively analyze and manage the burden put on patients and sites so that all parties may benefit from the research conducted efficiently and ethically.
  • In addition to achieving a finely tuned study protocol, typical benefits from this consultation and service are far-reaching.
  • In this way, Protocol Optimization can lead to maximizing value and investment in all areas of study execution.

Survey Shows One Third of Clinical Trial Study Sites Fear Total Closure; 77% Indicate at Least Some Ongoing Research Trials Have Been Impacted Due to COVID-19

Retrieved on: 
Wednesday, April 8, 2020

Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.

Key Points: 
  • Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.
  • Results from the 297 responding US sites show clinical research study sites not actively working on COVID-19-related studies have been heavily impacted by the global healthcare crisis.
  • These repercussions to the clinical research industry should raise alarm bells beyond just sponsors and CROs, said Continuum Clinical president Neil Weisman.
  • We specialize in identifying and solving challenges that can impact successful clinical trial enrollment, from protocol development through study completion.

New COVID-19 HOPE Clinical Trial Recommendations Introduced Today May Reduce or Eliminate Mechanical Ventilation for Coronavirus Patients

Retrieved on: 
Monday, March 30, 2020

Dr. Quay is making this new clinical trial protocol (called the COVID-19 HOPE Trial) available for use by the worldwide medical community.

Key Points: 
  • Dr. Quay is making this new clinical trial protocol (called the COVID-19 HOPE Trial) available for use by the worldwide medical community.
  • Starting today, doctors around the world are invited to directly download the protocol free of charge at www.DrQuay.com .
  • Nebulized H-NAC could become a valuable new tool for frontline COVID-19 treatment, as it should reduce or eliminate the need for a mechanical ventilator.
  • NAC is also FDA-approved in an inhalation formulation for a wide range of pulmonary conditions, although not for COVID-19 patients.

Algernon Appoints Novotech as CRO For Phase 2 Coronavirus Ifenprodil Trial

Retrieved on: 
Friday, March 20, 2020

Novotech will be working to assist the investigators of the planned study, including supporting all aspects of the clinical trial.

Key Points: 
  • Novotech will be working to assist the investigators of the planned study, including supporting all aspects of the clinical trial.
  • After the trial is approved, the Company will provide full details on the study protocol and timelines.
  • The Company also wishes to advise that it has retained Novotech to conduct a feasibility study in Australia for a phase 2 sponsor initiated Ifenprodil COVID-19 trial.
  • Novotech was a natural CRO choice for us to help to support this important investigator-led clinical trial, said Christopher J. Moreau CEO of Algernon Pharmaceuticals.

Survey Indicates COVID-19 to Negatively Impact Clinical Trial Enrollment and Retention

Retrieved on: 
Monday, March 16, 2020

(Graphic: Business Wire)

Key Points: 
  • (Graphic: Business Wire)
    Continuum Clinical, a global clinical trial enrollment company specializing in fact-based strategies, conducted the quantitative study on March 12-13 with 170 clinical trial sites in the US.
  • Initial results indicate multiple areas of concern for study sites, highlighting an expected significant impact on clinical trial recruitment.
  • Continuum Clinical is a global clinical trial enrollment company, providing fact-based patient recruitment solutions that deliver results.
  • We specialize in identifying and solving challenges that can impact successful clinical trial enrollment, from protocol development through study completion.

STATKING Clinical Services Named to the 15th Annual Aggie 100, Honored as Fastest Growing Company

Retrieved on: 
Wednesday, October 30, 2019

The Aggie 100 is founded and sponsored by the McFerrin Center for Entrepreneurship at Texas A&M University.

Key Points: 
  • The Aggie 100 is founded and sponsored by the McFerrin Center for Entrepreneurship at Texas A&M University.
  • Dr. King commented: We are truly honored to be named to this prestigious list of companies.
  • As we mark the 15th Crystal Anniversary of the Aggie 100 program, we celebrate our success by raising up the newest class of Aggie 100 honorees.
  • STATKING Clinical Services provides clinical trial services (clinical trial management, protocol development, biostatistics, clinical data management, clinical study monitoring, medical writing, medical monitoring, safety reporting, and project management) for clinical trials for the regulatory approval of novel drug and medical device products.

Cave Consulting Group (“CCGroup”) Success Stories on Healthcare Clinical Transformation

Retrieved on: 
Thursday, August 1, 2019

CCGroup works with CCGroup National Specialist Panels to develop and maintain the Clinical MedMarker Protocol Ranges, which are achievable, appropriate ranges of clinical practice.

Key Points: 
  • CCGroup works with CCGroup National Specialist Panels to develop and maintain the Clinical MedMarker Protocol Ranges, which are achievable, appropriate ranges of clinical practice.
  • This effort with our panels helps to ensure the validity of established Clinical MedMarker Protocol Ranges, stated Dr. Douglas G. Cave , President of CCGroup.
  • Our clients use their medical condition MedMarker results to support clinical transformation efforts, stated Yuri Alexandrian , COO/CIO of CCGroup.
  • Cave Consulting Group, Inc. is a software and consulting firm located in San Mateo, California.