Medical writing

EPNextS Group and Frontage Laboratories, Inc. Announce Collaboration in Early Phase Clinical Trials in the United States to Improve "Drug Lag" and "Drug Loss" Issues in Japan

Retrieved on: 
Tuesday, March 26, 2024
Medical writing, EPS, Patient, Project management, Clinical trial, Drug development, Data management, Pharmaceutical industry

"Our collaboration with Frontage underscores our commitment to advancing clinical research and improving patient access to innovative therapies.

Key Points: 
  • "Our collaboration with Frontage underscores our commitment to advancing clinical research and improving patient access to innovative therapies.
  • EPS and Frontage intend to conduct collaborative business development activities in Japan and the United States to expand market reach and conduct early phase clinical trials in Japanese and non-Japanese populations in the United States.
  • Frontage brings a wealth of experience in early-phase clinical research, including bioanalytical services, clinical pharmacology, and clinical operations.
  • "We are pleased announce this collaboration with EPNextS Group to address the pressing challenges facing the Japanese pharmaceutical industry," said Abdul Mutlib, CEO of Frontage.

ScienceMedia Welcomes Visionary Leaders to Advisory Board, Paving the Way for a New Era of Innovation

Retrieved on: 
Thursday, March 21, 2024
SCOPE, Software as a service, Growth, AstraZeneca, Patient, SAN, Acquisition, Corporate Affairs, Senior, Clinical trial, Therapy, Summit, Medical writing, Pharmaceutical industry

Their unparalleled insights—from patient-centric approaches to cutting-edge AI advancements—will fuel our mission to drive a transformative revolution in clinical trials."

Key Points: 
  • Their unparalleled insights—from patient-centric approaches to cutting-edge AI advancements—will fuel our mission to drive a transformative revolution in clinical trials."
  • Their insight will accelerate our growth and allow us to continue solving the most challenging therapeutic and clinical issues facing the industry."
  • Bierstein continues, "Embracing the spirit of innovation and collaboration, our esteemed advisory board represents the vanguard of change in the pharmaceutical and biotech sectors.
  • For further insights into ScienceMedia's groundbreaking initiatives and the dawn of a new era in clinical mastery, click here .

Calian Wins Contract to Support Clinical Trial for ZYUS Life Sciences’ Lead Drug Product Candidate

Retrieved on: 
Tuesday, February 20, 2024
CGY, Clinical trial, TSX, Pain, Data management, Learning, Safety, Contract research organization, Chronic pain, Patient, Knowledge, Medical writing, Partnership, Pharmaceutical industry

Calian's full-service Contract Research Organization (CRO) will apply its extensive clinical trial management experience to support a Phase 2 Clinical Trial for Trichomylin softgel capsules.

Key Points: 
  • Calian's full-service Contract Research Organization (CRO) will apply its extensive clinical trial management experience to support a Phase 2 Clinical Trial for Trichomylin softgel capsules.
  • “Calian will apply our industry-leading expertise to support this Phase 2 Clinical Trial and further ZYUS’ pursuit of transformational impact on patients’ lives,” says Derek Clark, President, Calian Health.
  • Calian will provide full-service, end-to-end expertise to support this trial, including medical writing, regulatory affairs, clinical operations, site monitoring, data management, medical monitoring and quality assurance.
  • By collaborating with an industry leading contract research organization with extensive experience in clinical trial management, we can leverage invaluable knowledge and expertise."

MMS Supported MAPS Public Benefit Corporation NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD

Retrieved on: 
Wednesday, December 13, 2023
Veterans, Defense, Other Health, Other Science, Pharmaceutical, Research, Software, Mental Health, Professional Services, Data Management, Science, Practice Management, Technology, Physical Therapy, Clinical Trials, Managed Care, Data Analytics, Health, Military, NDA, Medical writing, Post-traumatic stress disorder, PBC, MDMA, MMS, Psychotherapy, MAPS, FDA, New Drug Application, Contract research organization, PTSD, Pharmacovigilance, Pharmaceutical industry, Risk management

MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.

Key Points: 
  • MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.
  • MAPS PBC is developing investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD).
  • Over a year ago, MAPS PBC selected MMS as its CRO partner for the development of NDA for MDMA-assisted therapy for PTSD.
  • We are grateful to MAPS PBC for entrusting MMS to be a part of this process.”
    As MAPS PBC’s CRO, MMS provided regulatory strategy and operations, pharmacovigilance, medical writing, and biometrics services.

Fortrea Appoints Life Science Executive Dr. John Doyle to Lead Consulting Team

Retrieved on: 
Friday, October 13, 2023
Engineering, Columbia University Mailman School of Public Health, Faculty, Consultant, Drug development, Abstract, Vaccine, Doctorate, Publishing, Professional degrees of public health, Columbia University, Outline of health sciences, Business administration, Office for Life Sciences, Public, Growth, Medical writing, Cornell University, Applied economics, Science, Economics, Pfizer, Life, Silicon, Patient, Public health, Pharmaceutical industry, Epidemiology

Doyle will serve on Fortrea’s leadership team and lead a team of consultants and advisors with expertise that spans early development through lifecycle management.

Key Points: 
  • Doyle will serve on Fortrea’s leadership team and lead a team of consultants and advisors with expertise that spans early development through lifecycle management.
  • “Pharmaceutical and biotechnology innovators must constantly navigate complex and fast-changing business and regulatory environments to achieve their mission,” said Tom Pike, chairman and chief executive officer of Fortrea.
  • “John has extensive industry knowledge and distinctive technical skills that translate to tremendous value for customers.
  • “The biopharma industry is relentless in advancing science to improve patient outcomes and Fortrea is uniquely positioned to help,” said Dr. Doyle.

Biologics Consulting Appoints Dr. Margaret K. Vernon As Its New Chief Executive Officer

Retrieved on: 
Thursday, September 21, 2023
Research, Medical Devices, FDA, Consulting, Professional Services, Biotechnology, Pharmaceutical, Health, Science, Other Science, Vaccine, PPD, Communication, Developmental psychology, PRO, Pennsylvania State University, Clinical trial, Statistics, Thermo Fisher Scientific, Consultant, State College, Pennsylvania, Wharton, Medical writing, Management

Biologics Consulting Group, Inc. is pleased to announce the appointment of Dr. Margaret K. Vernon as Chief Executive Officer, effective September 18, 2023.

Key Points: 
  • Biologics Consulting Group, Inc. is pleased to announce the appointment of Dr. Margaret K. Vernon as Chief Executive Officer, effective September 18, 2023.
  • Dr. Vernon joins Biologics Consulting Group after 17 years with Evidera, a business unit of PPD.
  • “We are delighted to welcome Margaret to the Biologics Consulting management team,” stated Dr. Norman W. Baylor, former President, and CEO of Biologics Consulting.
  • Margaret is sure to serve as an excellent leader for the Biologics Consulting team as they help clients to advance the future of vaccines, biologics, drugs, and medical devices.” Dr. Vernon will succeed Dr. Baylor, who will remain as Chair of the Biologics Consulting Board of Directors.

EQS-News: Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division

Retrieved on: 
Tuesday, September 5, 2023
West Pharmaceutical Services, GMP, GLP, Laboratory, Drug development, Investigational New Drug, Clinical Laboratory, History, JMI, TIC, Chemistry, San Francisco Bay Area, CLIA, CDMO, Head, Contract research organization, Inspection, Knowledge, Testing, inspection and certification, FDA, IND, Medical writing, Fine chemical, Element, Certification

Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division

Key Points: 
  • Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division
    The issuer is solely responsible for the content of this announcement.
  • Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division
    05 September 2023 – Element Materials Technology (Element), a leading global Testing, Inspection and Certification (TIC) company, has launched an integrated offering for its pharmaceutical services.
  • With the unveiling of our integrated pharmaceutical services platform, Element Life Sciences now stands ready to address these challenges head-on.
  • Element Life Sciences stands as a steadfast partner, empowering pharmaceutical companies to overcome obstacles and advance their groundbreaking innovations in the dynamic and ever-evolving landscape of the life sciences industry.

Avance Clinical at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients

Retrieved on: 
Tuesday, May 30, 2023
Data management, Telehealth, Reuters, Therapy, GlobalData, Private, Clinical trial, Pharmacokinetics, DCT, Element, ASCO, Global Health, AUS, Science, Patient, SAN, Drug combination, Biostatistics, FDA, Medical writing, Nursing, Management, Pharmaceutical industry, Avance

Avance Clinical's Chief Scientific Officer, Gabriel Kremmidiotis

Key Points: 
  • Avance Clinical's Chief Scientific Officer, Gabriel Kremmidiotis
    According to Avance Clinical's Chief Scientific Officer Gabriel Kremmidiotis who is part of the Avance Clinical team attending ASCO:
    "Recently, Phase I clinical trial designs in Oncology patients have become more elaborate and include elements of dose escalation, dose expansion and assessment of drug combinations.
  • This, in addition to the increasing number of new emerging therapeutics, has increased the demand for fast progress through the early phases of development and a greater demand for access to patients."
  • "Utilizing Australia's regulatory environment and high-quality oncology experts, Avance Clinical is able to facilitate a fast project launch and seamless transition across different parts of modular oncology protocol designs.
  • Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in decentralised clinical trials (DCT) technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.

Catalyst Clinical Research Announces the Acquisition of Genpro Research

Retrieved on: 
Thursday, July 20, 2023
Real-World Evidence, Partnership, Senior, CSO, Culture, Biotechnology, Organization, Acquisition, Medical writing, RWE, AI, Medtech, Family, Catalysis, Automation, Medical device, Fine chemical, Genevation GenPro

WILMINGTON, N.C., July 20, 2023 /PRNewswire/ -- Catalyst Clinical Research ("Catalyst"), an industry-leading provider of specialized clinical development solutions, announced today it has acquired Genpro Research ("Genpro"), a Massachusetts-based global clinical research organization with staff in the US, India, and Ireland.

Key Points: 
  • WILMINGTON, N.C., July 20, 2023 /PRNewswire/ -- Catalyst Clinical Research ("Catalyst"), an industry-leading provider of specialized clinical development solutions, announced today it has acquired Genpro Research ("Genpro"), a Massachusetts-based global clinical research organization with staff in the US, India, and Ireland.
  • Commenting on the announcement, Catalyst CEO Nick Dyer said, "We are hugely enthusiastic about the addition of Genpro to our family.
  • We are excited to utilize the synergies in advancing our AI/ML technology platform to create beneficial new tools and improve the efficiency of clinical research.
  • Melissa Church, Senior Vice President, Strategy at Catalyst, expressed the strategic significance of the acquisition, emphasizing its importance in advancing Catalyst's commitment to providing top-notch specialized clinical development solutions.

iuvo BioScience Hires Industry Executive to Lead Clinical Research Team

Retrieved on: 
Tuesday, July 18, 2023
MSJ, Drug development, Data management, Safety, Protocol, Clinical research, Chairperson, Knowledge, Growth, Seton Hall University School of Law, Medical writing, Reata Pharmaceuticals, Biostatistics, BioScience, Pharmaceutical industry, Management, Science, Jurisprudence, Medication

ROCHESTER, N.Y., July 18, 2023 /PRNewswire-PRWeb/ -- iuvo BioScience, a specialty CRO providing laboratory services, preclinical and clinical development services, and scientific consulting services to pharmaceutical and medical device customers, today announced it has hired Lacey Powers, MSJ as its new VP, Clinical Research. This hire demonstrates iuvo's ongoing commitment to serving our clients, delivering differentiated expertise across our service offerings, and continued investment in the clinical research business to support the company's growth trajectory.

Key Points: 
  • iuvo BioScience, a specialty CRO providing laboratory services, preclinical and clinical development services, and scientific consulting services to pharmaceutical and medical device customers, today announced it has hired Lacey Powers, MSJ as its new VP, Clinical Research.
  • ROCHESTER, N.Y., July 18, 2023 /PRNewswire-PRWeb/ -- iuvo BioScience, a specialty CRO providing laboratory services, preclinical and clinical development services, and scientific consulting services to pharmaceutical and medical device customers, today announced it has hired Lacey Powers, MSJ as its new VP, Clinical Research.
  • Powers is an experienced clinical research executive who brings over twenty years of diverse experience to this role.
  • Daniel Spasic, Board Chair of iuvo BioScience, said, "We are excited to welcome Lacey to the iuvo family and our clinical development organization.