Clinical research - Today Stories

Chicago, IL (May 25, 2023) — Advanced Clinical, a privately held clinical research services organization committed to providing a better clinical experience across the drug development journey, is pleased to announce a biopharmaceutical industry-first collaboration with StuffThatWorks, the first data-driven community platform that uses crowdsourcing and AI to transform patient journeys and health metrics into actionable real world data in an effort to streamline research and bring clinical research closer to patients and caregivers. StuffThatWorks is home to 3M members world-wide who share their medical history and update on key condition and treatment parameters on an ongoing basis, in standard form across 750 conditions. Data shared by patients now amounts to 1.3M structured data points…

Company receives highest average rating across all 26 performance attributes out of 34 CROs included in survey and highest Net Promoter Score demonstrating likelihood to be recommended to colleagues DURHAM, N.C., May 31, 2023 (GLOBE NEWSWIRE) -- Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced it has been rated the “Top CRO to Work With” by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey. Among the 34 CROs included in the survey, Parexel received the highest average rating across all 26 performance attributes evaluated. “Study start-up has significantly increased in complexity and the pressure on investigative sites has never…

Global biopharmaceutical services provider Allucent has partnered with THREAD, an innovative decentralized clinical trial (DCT) and eCOA technology provider, to launch Allucent Patient Direct Trials, a DCT offering focused on small and mid-sized biotech companies. Allucent Patient Direct Trials provides small and mid-sized biotech companies with access to advanced technologies, operational experience, and regulatory expertise to design and execute more patient-focused trials and realize the efficiencies of a DCT approach. The announcement coincides with the 2023 World Orphan Drug Congress, where Allucent will lead a panel session on the value of decentralized study designs and protocol optimization, especially for rare disease therapeutic development.  CARY, N.C., May 23, 2023 – Global b…

Tomorrow is #ClinicalTrialsDay 2023, a day dedicated to shining a spotlight on the clinical research community. Organised and promoted by ACRP since 2014, the day is celebrated on May 20th to recognise the day that James Lind started what is considered the first randomised clinical trial on May 20th, 1774. The day presents an opportunity for the community to pause in reflection, recognition, and admiration of all that has been accomplished thanks to clinical trials and the talented professionals driving them. Find out more about how you can get involved in #CTD2023: https://www.clinicaltrialsday.org/getinvolved

UK-based Contract Research Organisation (CRO) Gentronix – a leading specialist toxicology CRO – has announced the next phase in its ongoing growth plan with the opening of a brand-new 2,819 sq ft laboratory and office suite at Alderley Park. The newly established suite will accommodate the activities of the Big Blue® transgenic rodent mutation workflow, increasing capacity in this in-demand mutagenesis toxicology test and growing the Gentronix footprint at Alderley Park by 30%. This continued growth follows a successful 2300 sq ft. expansion in 2021 to increase capacity of genetic, ocular, and skin toxicology testing in 2021. Gentronix completed the acquisition of the Big Blue® transgenic rodent mutation assays in June 2021 and have subsequently undertaken an extensive proficiency exercise…

A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK. These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers. Under the new framework, clinical trials application processes in UK will be more proportionate, streamlined and flexible without compromising on safety, helping to cement the UK as an attractive destination for trials, including global “multi-site” trials. For example, the integration of the regulatory and ethics reviews of clinical trial applications, w…

BALLERUP, DENMARK and DUBLIN, IRELAND — 10 March, 2023 — LEO Pharma, a global leader in medical dermatology, and ICON plc (NASDAQ: ICLR) today announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost effective, and which will support the company’s overall ambition of building one of the most effective and efficient clinical portfolio execution organisations in the industry. The mission of the partnership is to improve the lives of dermatology patients with access to innovative clinical trials and the launch of new medicines. The partnership will operate under the acronym of PACE, reflecting the requirement to move quickly to address today’s clinical development challenges. It also represents LEO Pharma and ICON’s share…

Seeks to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and treat nervous systems disorders WILMINGTON, N.C.--(BUSINESS WIRE)-- The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been awarded a five-year contract to provide regulatory affairs support and related services for the Blueprint MedTech (BPMT) program, a new multi-institute/center initiative at the National Institutes of Health (NIH) supporting development of translational neurological devices. The BPMT program is a new NIH incubator with a collaborative reach across 11 NIH institutes, whose goal is to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and/or treat disorders of the nervous system.…

HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs). Clinical phase 1/2 study (LAPiS Study) will enrol 10 patients with advanced heart failure caused by ischaemic heart disease. Tokyo, Japan and Bagsværd, Denmark, 10 February 2023 – Heartseed Inc. (Heartseed) and Novo Nordisk A/S today announced that Heartseed has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with HS-001 – an investigational cell therapy for heart failure. An independent safety evaluation committee has evaluated 4-week data on the patient, who lives with advanced heart failure and has given approval for the study to continue. Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood…

Study published today in Clinical Trials: Journal of the Society for Clinical Trials examined clinical trial diversity across 495 GSK trials involving over 100,000 participants Results demonstrate real-world disease epidemiology data—compared to the conventional standard of US Census data—may be better benchmark to ensure clinical trial enrolment reflects the populations affected by diseases GSK commits to applying insights from the study and collaborating with regulators, patients, academics and other biopharma companies to make meaningful progress on clinical trial diversity GSK plc (LSE/NYSE: GSK) today announced results from a retrospective study on clinical trial diversity, investigating the historical representation of US-based participants in GSK clinical trials. The study looked…

New collaboration leverages MyEyeDr.’s 850+ offices across the US to refer patients into ophthalmology and other therapeutic area clinical trials, expands Parexel’s Community Alliance Network to bring trials to patients where they are BOSTON and DURHAM, N.C., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced a formal agreement with MyEyeDr., a leading vision healthcare organization, to refer its patients into existing and future ophthalmology clinical trials. Parexel and MyEyeDr. are currently collaborating on recruitment for a diabetic retinopathy clinical trial with future plans to expand into additional therapeutic areas such as endocrinolog…

Milton Keynes, UK. (6 December 2022) – Medical Research Network, a leading Clinical Trial Organization, was presented with the Queen’s Award for Enterprise, International Trade at a company meeting last night. The award, established by Her Majesty Queen Elizabeth in 1965, celebrates the country’s most exciting and innovative companies, and is Britain’s most prestigious business award. The International Trade category is awarded to companies who have achieved spectacular growth and commercial success overseas. The presentation took place at a company-wide meeting held at the Wyboston Lakes Resort, near the MRN headquarters in Milton Keynes. MRN executives from France, Germany, Spain, and Japan were there to watch the presentation in person, while executives from the MRN office in Chicago wa…

Data presented at CTAD 2022 confirm excellent clinical performance of ACI-35.030 vaccine candidate Based on this new clinical data, ACI-35.030 has been selected for further development representing significant progress for the anti-pTau vaccine candidate AC Immune vaccine portfolio targeting three hallmark proteins of neurodegenerative diseases now progressing through advanced clinical development Lausanne, Switzerland, November 30, 2022 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development. The ACI-35.030 anti-pTau vac…

Partnership between the University of Birmingham and Acticor Biotech will see patients with heart attacks treated with glenzocimab, a promising new class of drug for the first time. A potential new drug to improve the long-term outcomes for heart attack patients will be trialled in the UK. With the signing of a partnership between the University of Birmingham and Acticor Biotech, a new clinical trial called LIBERATE will take place in two acute care hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield. The randomised, double-blind Phase 2b LIBERATE study will recruit more than 200 patients to test the tolerance and the efficacy of glenzocimab 1000 mg, versus placebo, to reduce heart damage following a myocardial infarction (MI), commonl…

Bagsværd, Denmark, 22 November 2022 – Novo Nordisk today announced plans to invest 5.4 bn Danish kroner in the expansion of existing facilities in Bagsværd. The plans also include the construction of a new plant located in extension of the existing facilities. The investment will establish additional capacity in R&D for manufacturing of active pharmaceutical ingredients (API) to supply our global clinical trials. These expansions will provide capacity for developing Novo Nordisk’s future oral and injectable product portfolio. “This investment in expanding our clinical API capacity in Bagsværd is an important step to ensure the continuous progress of our development pipeline. Increasing our API capacity in R&D will be a key enabler in bringing new innovations to the market, and meet…

London, U.K., 17 November 2022: Velocity Clinical Research (“Velocity”), the leading integrated research site organisation, today announces its expansion into the U.K. with the acquisition of multi-site company Egin Research. Velocity is the first US-based clinical research sites business to expand into Europe, bringing its total number of dedicated research locations to 42. The addition of Egin Research’s two sites increases Velocity’s European site footprint to three, after its first European purchase in Hamburg, Germany in July 2022 and further growth expected over the next 12 months. Dominic Clavell, Executive Vice President, Europe, said, “The size and importance of the UK market for clinical research cannot be underestimated. There is a focus on clinical trial regulation reform in a…

$97 million investment enhances bioanalytical services, helping pharma and biotech customers accelerate drug development WILMINGTON, N.C.--(BUSINESS WIRE)-- Thermo Fisher Scientific, the world leader in serving science, today expanded its clinical research operations with the opening of a state-of-the art bioanalytical lab in Richmond, Virginia. The new unit will support increasing demand across biopharma for consistent, high-quality laboratory services to accelerate drug development. The 59,000-square-foot facility is part of the previously announced $97 million investment by the company to expand its bioanalytical laboratory operations in Richmond and add more than 500 jobs over the next three years. The current laboratory services operation in Richmond, which Thermo Fisher acquired thro…

Quanticate, a global data-focused clinical research organisation (CRO), has partnered with leading cancer research organisation, Cancer Research UK, to launch the DETERMINE study which will test a range of therapies specifically targeting key genetic changes in cancer cells.  The first of its kind in the UK, the DETERMINE study will enrol patients with rare cancers, and aim to find out whether existing licensed drugs could be used to treat their type of cancer. Cohorts will be formed of patients who have an identifiable genetic alteration in their cancer that can be targeted by treatments already approved for use in other cancer types.  Quanticate has been working with Cancer Research UK’s Centre for Drug Development to ensure the statistical design of the study is optimised.  “The study w…

Opportunity to provide digital data and decentralized trial services for multi-institutional cancer trials led by NCI-supported organizations WILMINGTON, N.C.--(BUSINESS WIRE)-- The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been awarded a 10-year Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract by the National Cancer Institute (NCI), part of the National Institutes of Health, to support NCI’s Cancer Trials Support Unit (CTSU). As part of the award, the PPD clinical research business will have the opportunity to coordinate the resources and processes necessary to identify, deploy, support and maintain a platform for the collection and migration of electronic patient-reported outcomes (ePROs) and other patient-generated…

Key leadership appointments focused on enhancing connections and collaboration to drive Innovation across the next-generation delivery of clinical trials and fuel more integrated, therapeutically-focused solutions for patients BOSTON and DURHAM, N.C., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO), today announced the promotions of Peyton Howell to the newly-created role of Chief Operating and Growth Officer and Amy McKee, MD, to Chief Medical Officer and Global Head, Oncology Center of Excellence. These moves are designed to strengthen the company’s medical and scientific focus and support its continued record growth through closer alignment of all aspects of strategy, sales and delivery to delight customers, build repeat business and lea…