Clinical Trial Service Unit

DLA Piper Advises Arlington Capital Partners and Everest Clinical Research in Its Acquisition of August Research

Retrieved on: 
Monday, December 18, 2023
Professional Services, Health, Legal, Research, Science, Pharmaceutical, Biotechnology, Acquisition, ACP, DLA Piper, Clinical trial, Piper, Biostatistics, DLA, Arlington Capital Partners, Clinical Trial Service Unit, CTS, Pleasure, European, Mount Everest, Pharmacovigilance

DLA Piper advised Arlington Capital Partners (ACP) and Everest Clinical Research (Everest), a leading full-service contract research organization (CRO) with expertise in biostatistics and statistical programming, in its acquisition of August Research (August), a European CRO that provides Clinical Trial Services (CTS) and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients.

Key Points: 
  • DLA Piper advised Arlington Capital Partners (ACP) and Everest Clinical Research (Everest), a leading full-service contract research organization (CRO) with expertise in biostatistics and statistical programming, in its acquisition of August Research (August), a European CRO that provides Clinical Trial Services (CTS) and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients.
  • The acquisition of August establishes a European base for Everest to provide CTS to its clients and expand its operational capabilities through August’s presence across 14 countries in Western and Eastern Europe.
  • “The acquisition of August further expands Everest’s global service offerings and establishes a foothold in one of the largest clinical trial markets in the world,” said Jeffrey Houle, co-chair of DLA Piper’s Aerospace, Defense and Government Services Transactional Practice, who led the deal team.
  • The firm has been rated number one in global M&A volume for 12 consecutive years, according to Mergermarket.

Everest Clinical Research Announces the Acquisition of August Research

Retrieved on: 
Tuesday, November 7, 2023
Technology, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Data Management, Science, Dai, Arlington Capital Partners, CTS, Acquisition, Clinical Trial Service Unit, Data management, Clinical trial, Partnership, Partner, Biostatistics, Pharmaceutical industry, European, Pharmacovigilance, Mount Everest

Everest Clinical Research (“Everest”), a leading full-service contract research organization (“CRO”) with deep expertise in clinical data management, biostatistics and statistical programming, today announced it has acquired August Research (“August”).

Key Points: 
  • Everest Clinical Research (“Everest”), a leading full-service contract research organization (“CRO”) with deep expertise in clinical data management, biostatistics and statistical programming, today announced it has acquired August Research (“August”).
  • Everest is a portfolio company of Arlington Capital Partners (“Arlington”), a Washington, D.C. based private equity firm with extensive experience investing in regulated industries.
  • Their expertise in and dedication to the field of clinical research are truly impressive.
  • The combination of Everest and August Research’s capabilities will provide a global, full suite of clinical services to its broad client base, accelerating growth opportunities for the merged company.

Unique Sourcing Solutions to Optimize Time and Budget in Clinical Trial, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, October 30, 2023
Clinical trial, Clinical Trial Service Unit, Pharmaceutical industry, Health insurance, Dietary supplement

TORONTO, Oct. 30, 2023 /PRNewswire-PRWeb/ -- The challenge of running successful global trials is highly demanding and has become increasingly costly. Sourcing commercially available medications for these trials can be both complex and resource intensive. Therefore, it is essential to set up and implement the best comparator sourcing strategy right from the start.

Key Points: 
  • Attendees will learn about the pros and cons of different options and the key considerations when choosing the appropriate sourcing option(s) for specific clinical trial needs.
  • The featured speaker will discuss how to work strategically vs. transactionally to provide guaranteed supply while lowering spending.
  • This webinar will introduce innovative sourcing strategies for commercially available medications while assessing the pros and cons of the different options.
  • Join Michelle Novak, Director Business Development, North America, Clinical Trial Services, Inceptua , for the live webinar on Friday, November 10, 2023, at 1pm EST (10am PST).

Volition Presents Three Cancer Detection Abstracts at ESMO 2023

Retrieved on: 
Monday, October 16, 2023
Diagnosis, Lung cancer, NYSE, Biomarker, Plasma, University, Volition, Cancer, Nucleosome, National Taiwan University Hospital, ESMO, Oncology, Université de Namur, Research institute, Clinical Trial Service Unit, Nucleic acid thermodynamics, European Society for Medical Oncology, CTCF, Glioblastoma, Malignancy, Poster, Nursing

HENDERSON, Nev., Oct. 16, 2023 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, is presenting three scientific abstracts at ESMO 2023, the annual congress of the European Society for Medical Oncology.

Key Points: 
  • HENDERSON, Nev., Oct. 16, 2023 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, is presenting three scientific abstracts at ESMO 2023, the annual congress of the European Society for Medical Oncology.
  • Dr. Jake Micallef, Chief Scientific Officer at Volition, said: "We are delighted to be attending ESMO 2023 and have the opportunity to share exciting new data in lung cancer and glioblastoma, and introduce what we believe to be an entirely new method for the detection of cancer."
  • On Saturday 21st October, Dr. Dorian Pamart, Head of Technology and Service Unit at Volition, will present a poster (205P) titled 'A novel immunoprecipitation/PCR method for detection of plasma cfDNA fragments selectively occupied by CTCF in cancer'.
  • The study was undertaken by Volition and the National Taiwan University Hospital and is part of a longer-term research collaboration.

RQM+™ Selects THREAD to Power New Medical Device Research Offering

Retrieved on: 
Tuesday, July 25, 2023
Research, Medical Devices, Consulting, Clinical Trials, Health Technology, Professional Services, Biotechnology, Health, Science, Partnership, Patient, American Opportunity Tax Credit, Medtech, Clinical Trial Service Unit, Cryptocurrency, Pharmaceutical industry, RQM

RQM+, the world’s leading MedTech service provider, and THREAD, a leading decentralized research and eCOA provider, today announced the launch of a strategic partnership designed to transform the landscape of MedTech research.

Key Points: 
  • RQM+, the world’s leading MedTech service provider, and THREAD, a leading decentralized research and eCOA provider, today announced the launch of a strategic partnership designed to transform the landscape of MedTech research.
  • This partnership will engage THREAD’s technology across RQM+’s portfolio of medical devices, diagnostic products, and digital therapies to support manufacturers with accelerating research and bringing new products to market faster.
  • “Our strategic partnership enables MedTech clinical research, manufacturers, sites, and patients to unlock the potential for personalized breakthroughs and a future of targeted therapies.
  • “We are excited RQM+ selected THREAD as its partner to enable its new offering, which aligns with our mission to advance research for everyone, everywhere.”

Societal CDMO Enters Agreement With Atossa Therapeutics to Provide Clinical Trial Services (CTS) for Innovative Selective Estrogen Receptor Modulator

Retrieved on: 
Tuesday, May 23, 2023
Clinical Trial Service Unit, Society, CTS, SERM, CDMO, SAN, Engineering, R, Technology transfer, Fine chemical, Atossa

SAN DIEGO and GAINESVILLE, Ga., May 23, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected by Atossa Therapeutics (Nasdaq: ATOS ) to provide a range of its Clinical Trial Services (CTS) offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen.

Key Points: 
  • SAN DIEGO and GAINESVILLE, Ga., May 23, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected by Atossa Therapeutics (Nasdaq: ATOS ) to provide a range of its Clinical Trial Services (CTS) offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen.
  • The agreement spans a range of activities including analytical method transfer/development and validation, cleaning verification method validation, manufacturing of multiple R&D engineering batches, and stability testing of the R&D engineering batches.
  • “Societal’s demonstrated expertise in the technology transfer of established drug products, along with our long track record of successfully formulating and manufacturing innovative small molecules, positions us well to align with Atossa and support the ongoing clinical development of the company’s proprietary oral formulation of (Z)-endoxifen.
  • We are eager to initiate this important work and deliver exceptional results for Atossa,” said David Enloe, chief executive officer of Societal CDMO.

Societal CDMO Announces Signing of Multiple New CDMO Service Agreements

Retrieved on: 
Thursday, October 20, 2022
SAN, U.S. Securities and Exchange Commission, Drug Quality and Security Act, Interleukin, Steatorrhea, IND, GMP, Clinical Trial Service Unit, DEA, NASDAQ, Contract, NASD, Security (finance), Program, Science, Clinical trial, Securities Act of 1933, Cancer, Drug discovery, Society, CDMO, Securities Exchange Act of 1934, Phrase, Excipient, GLOBE, COVID-19, Pharmaceutical industry, Fine chemical

SAN DIEGO and GAINESVILLE, Ga., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (Societal CDMO; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has signed CDMO service agreements with two new customers.

Key Points: 
  • SAN DIEGO and GAINESVILLE, Ga., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (Societal CDMO; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has signed CDMO service agreements with two new customers.
  • Societal CDMOs activities will support a planned Phase 3 clinical trial as part of the customers ongoing clinical development program for the drug in the United States.
  • As part of the second agreement, Societal CDMO will conduct a range of activities supporting a new customers development of a novel interleukin-2 (IL-2) analog for the treatment of cancer.
  • The services provided by Societal CDMO will include formulation development, analytical method transfer and verification, and GMP batch manufacturing and fill/finish related to the program, which is currently in preclinical development.

Dr. Vince Clinical Research Hires Two Industry Veterans, Bringing Over 50 Years’ Combined Research Experience

Retrieved on: 
Tuesday, July 26, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, CEO, Investment, CRO, Clinical trial, Leadership, Clinical Trial Service Unit, Contract research organization, Technology, Hardage, Medicine, GMP, Pharmacy, Smarter Planet, Fine chemical

Dr. Vince Clinical Research (DVCR), a world-class contract research organization (CRO) specializing in early phase clinical trials, today announced the addition of two key leadership roles to its Phase I research team.

Key Points: 
  • Dr. Vince Clinical Research (DVCR), a world-class contract research organization (CRO) specializing in early phase clinical trials, today announced the addition of two key leadership roles to its Phase I research team.
  • Michelle Neaderhiser joins the organization as the Director of Study Management, leveraging her 25+ years of experience in clinical research.
  • Chris Hardage also joins DVCR with 25+ years of clinical research experience as the Director of Clinical Trial Services.
  • Dr. Vince Clinical Research (DVCR) is a world-class CRO (Contract Research Organization) with a custom-built, green-designed headquarters and research complex encompassing three buildings in Overland Park, KS.

Saol Therapeutics and InformedDNA Partner to Offer Genetic Counseling to Patients with Rare Mitochondrial Disease

Retrieved on: 
Tuesday, April 26, 2022
CEO, Pain management, Clinical trial, Degenerative disease, Pivotal, Genetics, Phase, Genomics, University, Caregiver, PDC, Learning, Congenital lactic acidosis, Patient, Genetic counseling, Topical steroid withdrawal, Sail, Spasticity, Review, Lists of diseases, Saol, Clinical Trial Service Unit, CLA, Solution, Mitochondrial disease, Health care, Pyruvate dehydrogenase complex, DCA, FDA, Disease, Partnership, Precision medicine, Therapy, Pharmaceutical industry, Medicine

ROSWELL, Ga. and ST. PETERSBURG, Fla., April 26, 2022 /PRNewswire/ -- Saol Therapeutics, a company researching new treatments for rare diseases, is pleased to announce a partnership with InformedDNA®, the nation's leading applied genomics solutions company, to offer genetic counseling for the families of individuals with a rare mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD).  The counseling will also review potential participation in a Phase 3 clinical trial. PDCD affects less than 300 children in the United States annually and lacks any FDA-approved treatment.

Key Points: 
  • After speaking with a genetic counselor, families interested in learning more about the clinical research study will be connected with a trial site.
  • Dave Penake, CEO of Saol Therapeutics, is pleased to partner with InformedDNA to provide this valuable service.
  • Healthcare providers and caregivers for children with Pyruvate Dehydrogenase Complex Deficiency (PDCD) may request a genetic counseling appointment by visiting www.InformedDNA/Saol .
  • Saol Therapeutics (pronounced "Sail") is a privately held, biopharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda.

Recro Reports Second Quarter 2021 Financial Results

Retrieved on: 
Monday, August 9, 2021
Credit, LIBOR, Excipient, Acquisition, Cancer, QP, Social, Growth, Risk, Review, Solution, Exercise, U.S. Securities and Exchange Commission, DuPont, ESG, Leadership, COVID-19, Securities Exchange Act of 1934, EBITDA, Blister, Therapy, Biotechnology, Security (finance), Credit agreements in South Africa, Clinical Trial Service Unit, Clinical trial, CDMO, Phrase, GAAP, Development, ID, CGMP, Securities Act of 1933, Conference, Employment, GLOBE, Economy of the European Union, NASD, Culture, Income, Food industry, Revenue, Athyrium, Patheon, Astex, DEA, Three Months Gone, Energy Independence and Security Act of 2007, CTS, Animal, Pharmaceutical industry, Management, Risk management, Bank, Lithium, Vaccine

EXTON, Pa., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (“Recro”; NASD:REPH), a dedicated contract development and manufacturing organization (CDMO) solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today reported financial results for the second quarter and six months ended June 30, 2021.

Key Points: 
  • ET
    EXTON, Pa., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Recro; NASD:REPH), a dedicated contract development and manufacturing organization (CDMO) solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today reported financial results for the second quarter and six months ended June 30, 2021.
  • This is a very exciting time at Recro, and today, the company is pleased to report strong second quarter earnings.
  • And finally, during and subsequent to the second quarter, the company continued to expand and enhance the business through leadership and talent.
  • Financial Results for the Three Months Ended June 30, 2021
    At June 30, 2021, Recro had cash and cash equivalents of $45.7 million compared to $23.8 million as of the end of the prior fiscal year.