Medical writing

APCER Life Sciences Awarded ISO 27001:2013 Certification: Achieves Gold Standard for Information Security Management System

Retrieved on: 
Monday, January 17, 2022
Data Management, Health, Technology, Software, General Health, Pharmaceutical, Biotechnology, Technology, United Kingdom Accreditation Service, Medication, ISMS, UKAS, Information, Solution, Privacy, HIPAA, Medical writing, Risk management, Certification, Compliance, Physician, Awareness, Medical device, Audit, Biotechnology

The globally recognized and accepted standard for Information Security Management System (ISMS) has been authorized by Intertek Certification Limited, UKAS (The United Kingdom Accreditation Service ISO accreditation body).

Key Points: 
  • The globally recognized and accepted standard for Information Security Management System (ISMS) has been authorized by Intertek Certification Limited, UKAS (The United Kingdom Accreditation Service ISO accreditation body).
  • APCERs Patients First approach enables it to deliver end-to-end drug safety, medical information, medical writing, regulatory affairs, quality assurance and risk management services to clients globally.
  • APCER Life Sciences, a part of the APC Group, realizes value in achieving this important milestone.
  • The ISO 27001:2013 Certification validates successful implementation of secure Information Security Practices which ensure compliance with global data protection regulations like EU-GDPR, UK-DPA, HIPAA etc.

Altasciences Acquires Sinclair Research and Continues to Expand Preclinical Platform

Retrieved on: 
Tuesday, January 4, 2022
Biotechnology, Consulting, Health, Professional Services, Pharmaceutical, Safety, Acquisition, Research, IND, Biostatistics, Sinclair Research, Toxicology, Data management, CRO, Drug development, Medical writing, Biotechnology, Â, NDA, Fine chemical, Management, U.S.A

Complementing existing locations on the East and West Coast, the new site will facilitate even greater access to Altasciences preclinical services across the U.S.A.

Key Points: 
  • Complementing existing locations on the East and West Coast, the new site will facilitate even greater access to Altasciences preclinical services across the U.S.A.
  • This acquisition will add significant capacity and expertise to Altasciences existing preclinical offering, said Steve Mason, Co-Chief Operating Officer at Altasciences.
  • Sinclairs experience conducting research on a wide variety of species in a comprehensive range of drug classes will broaden our current preclinical offering and support Altasciences focus on providing our clients with customized solutions.
  • Built on more than 50 years of experience, Sinclair Research provides services to support biopharmaceutical, animal health, and medical device development programs.

Telos Partners LLC Welcomes Industry Veteran Scott Day as Senior VP and General Manager to Accelerate Growth Strategy

Retrieved on: 
Tuesday, December 28, 2021
Professional Services, Medical Devices, Health, Consulting, General Health, Biotechnology, Technology, Publishing, Science and technology, Adoption, Gramercy, Leadership, Spine, Orthopediatrics, Partner, RFID, Biotechnology, Internationalized domain name, Growth, Industry, Strategic planning, NASDAQ, Medical writing, Goal, SR, General manager, Senior, Management, Risk management, Telos, Science

Scott assumes this role following the completion of Jason Inzanas time leading the Telos organization.

Key Points: 
  • Scott assumes this role following the completion of Jason Inzanas time leading the Telos organization.
  • Since being acquired by OrthoPediatrics, Telos has more than doubled the size of its team, streamlined its sales channel, and expanded its client base.
  • Scott is a medical technology veteran, uniquely equipped to lead the Telos team forward on this foundation.
  • As Senior Vice President of the Orthofix US orthopedic business unit, his leadership resulted in 31% growth during his 4+ year tenure.

North America Medical Device & Diagnostics CRO Market, Forecast to 2028 - Rising Number of Clinical Trials, Huge Competition - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 21, 2021
Medical Devices, Health, Carbon, Children's Healthcare of Atlanta, IBI Group, Mackinac Bridge Authority, Medical Innovation Bill, Face shield, Hope, Mackinac Bridge, MBA, LabCorp, COVID-19, ICON, PPE, Parexel, CAGR, Personal protective equipment, Partnership, Service, COVID, CRO, Bridge, Medical writing, Patient, Growth, Pharmaceutical industry, Medical device, IQVIA

The rising number of clinical trials in North America is the major factor driving the growth of the North America medical device and diagnostics contract research organization market.

Key Points: 
  • The rising number of clinical trials in North America is the major factor driving the growth of the North America medical device and diagnostics contract research organization market.
  • However, the issue associated with huge competition in CRO services market hinders the growth of North America medical device and diagnostics contract research organization market.
  • Based on type, the North America medical device and diagnostics contract research organization market is segmented into medical devices and diagnostic.
  • Based on country North America medical device and diagnostics contract research organization market is segmented into US, Canada, and Mexico.

Virpax Announces Clinical Trial Site in Canada for First in Human Study of Epoladerm™ for Pain Associated with Osteoarthritis of the Knee

Retrieved on: 
Monday, December 20, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, U.S. Securities and Exchange Commission, Central nervous system disease, Bupivacaine, Medical writing, FDA, Post-traumatic stress disorder, Company, Pain, Clinical trial, CTA, Severe acute respiratory syndrome coronavirus 2, Drug Quality and Security Act, Securities Exchange Act of 1934, Epilepsy, PTSD, Knee, CNS, Private Securities Litigation Reform Act, Industry, Biostatistics, COVID-19, Cancer, Nature, Securities Act of 1933, NASDAQ, Data management, Chronic pain, File, Biotechnology, Security (finance), Drug development, MET, Gel, CBD, Pain management, Osteoarthritis, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Technology, Lists of diseases, Pharmaceutical industry, Risk management, Epoladerm™, Virpax Pharmaceuticals, Altasciences, EPOLADERM™, VIRPAX PHARMACEUTICALS, ALTASCIENCES

The study will take place in Canada with a CTA filing and enrollment of the first patient anticipated by Q2 of 2022.

Key Points: 
  • The study will take place in Canada with a CTA filing and enrollment of the first patient anticipated by Q2 of 2022.
  • Performing trials in Canada is an efficient and cost-effective way for Virpax to add robust data in support of the 505(b)(2) FDA approval pathway for Epoladerm .
  • Virpax Pharmaceuticals is developing Epoladerm (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
  • Our proprietary technology provides a convenient aerosol canister for application of the spray film to the knee.

Altasciences Chosen by Respira Technologies, Inc. as Drug Product Manufacturing Partner for the World’s First Inhaled Nicotine Replacement Therapy (NRT)

Retrieved on: 
Tuesday, December 14, 2021
Retail, Medical Devices, Health, Tobacco, Pharmaceutical, Biotechnology, Food, Medical writing, FDA, Smoking, VMN, Creativity, IND, Biostatistics, Food and Drug Administration, Drug discovery, Data management, Risk, CEO, Research, Biotechnology, API, CGMP, Operation, Drug development, Investment, Technology, Pharmaceutical industry, Fine chemical

Altasciences pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the worlds first inhaled smoking cessation therapy.

Key Points: 
  • Altasciences pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the worlds first inhaled smoking cessation therapy.
  • Respira also plans to create a larger platform approach for active pharmaceutical ingredient (API) delivery, taking advantage of the multi-drug capabilities of their proprietary platform drug delivery system.
  • Altasciences is agile, flexible, and quick, while providing the proven expertise and capability required for cGMP pharma drug product manufacturing.
  • For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

Sobi continues the R&D transformation - Anders Ullman appointed new Head of R&D

Retrieved on: 
Monday, December 13, 2021
NeuroSearch, YouTube, Biostatistics, Medical writing, SEK, Sahlgrenska University Hospital, Nycomed, Pharmacology, Board, LinkedIn, Nasdaq Stockholm, D, R, Upjohn, Pharmacovigilance, Baxter, AstraZeneca, Knowledge, Leadership, Sorhagenia pexa, Doctor of Philosophy, Astra, Takeda, Degenerative disease, Management, Pharmaceutical industry, Fine chemical, Swedish Orphan Biovitrum, Middle East, North America, North Carolina

In support of the transformation, Dr Ullman will be based in Basel, Switzerland, report to CEO Guido Oelkers and become a member of the Sobi Executive Committee.

Key Points: 
  • In support of the transformation, Dr Ullman will be based in Basel, Switzerland, report to CEO Guido Oelkers and become a member of the Sobi Executive Committee.
  • Guido Oelkers: "We welcome Anders in his new capacity having served in 2021 on the Sobi Board of Directors.
  • Dr Ullman will leave the Sobi Board of Directors as a result of the management appointment.
  • In 2015, Dr Ullman returned to academia to head up a pulmonology unit at the Sahlgrenska University Hospital in Gothenburg, Sweden.

Sobi continues the R&D transformation - Anders Ullman appointed new Head of R&D

Retrieved on: 
Monday, December 13, 2021
NeuroSearch, YouTube, Biostatistics, Medical writing, SEK, Sahlgrenska University Hospital, Nycomed, Pharmacology, Board, LinkedIn, Nasdaq Stockholm, D, R, Upjohn, Pharmacovigilance, Baxter, AstraZeneca, Knowledge, Leadership, Sorhagenia pexa, Doctor of Philosophy, Astra, Takeda, Degenerative disease, Management, Pharmaceutical industry, Fine chemical, Swedish Orphan Biovitrum, Middle East, North America, North Carolina

In support of the transformation, Dr Ullman will be based in Basel, Switzerland, report to CEO Guido Oelkers and become a member of the Sobi Executive Committee.

Key Points: 
  • In support of the transformation, Dr Ullman will be based in Basel, Switzerland, report to CEO Guido Oelkers and become a member of the Sobi Executive Committee.
  • Guido Oelkers: "We welcome Anders in his new capacity having served in 2021 on the Sobi Board of Directors.
  • Dr Ullman will leave the Sobi Board of Directors as a result of the management appointment.
  • In 2015, Dr Ullman returned to academia to head up a pulmonology unit at the Sahlgrenska University Hospital in Gothenburg, Sweden.

Altasciences Chosen by XORTX Therapeutics, Inc. to Conduct Pharmacokinetic Bridging Study XRX-OXY-101 in Support of Developing New Therapies for Progressive Kidney Disease and Acute Kidney Injury

Retrieved on: 
Thursday, December 9, 2021
Research, Infectious Diseases, Consulting, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, Science, Human, Uric acid, Acute kidney injury, COVID-19, Biotechnology, Oxipurinol, Medical writing, ADPKD, Drug development, Autosome, CEO, Therapy, Biostatistics, Data management, Kidney disease, Polycystic kidney disease, Pharmaceutical industry

Altasciences is pleased to have been chosen by XORTX Therapeutics, Inc. to conduct a pharmacokinetic bridging study in support of the XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury associated with COVID-19.

Key Points: 
  • Altasciences is pleased to have been chosen by XORTX Therapeutics, Inc. to conduct a pharmacokinetic bridging study in support of the XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury associated with COVID-19.
  • Dr. Allen Davidoff, President and CEO stated, XORTX is pleased to be starting work with Altasciences as we initiate the characterization of our novel, proprietary formulations of xanthine oxidase inhibitors.
  • With a pressing need for better therapeutic options and a global prevalence of kidney disease, we are proud to partner with XORTX for such an important study.
  • For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

XORTX Therapeutics Appoints Altasciences as CRO for Clinical Study

Retrieved on: 
Thursday, December 2, 2021
Coronavirus diseases, Patient, Security (finance), News, CEO, Kidney disease, Uric acid, Analysis, Data management, Form, Health, ADPKD, Xanthine oxidase, Unitary state, Human, SEC, TSX Venture Exchange, U.S. Securities and Exchange Commission, Autosome, COVID-19, Biostatistics, Medical writing, GLOBE, CRO, Acute kidney injury, Diabetic nephropathy, Biotechnology, Polycystic kidney disease, Therapy, Drug development, NASDAQ, No, Oxipurinol, Quality of life, Pharmaceutical industry

Dr. Allen Davidoff, President and CEO stated, XORTX is pleased to be starting work with Altasciences as we initiate the characterization of our novel, proprietary formulations of xanthine oxidase inhibitors.

Key Points: 
  • Dr. Allen Davidoff, President and CEO stated, XORTX is pleased to be starting work with Altasciences as we initiate the characterization of our novel, proprietary formulations of xanthine oxidase inhibitors.
  • XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid.
  • At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future health of patients.
  • Altasciences integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring and data management, all customizable to specific sponsor requirement.