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• Breaking News | Clinical Trials | CRO News | Industry News | Information Technology
  

  Syneos Health, Aetion Partner on Regulatory-grade Data, Analytics Solutions

  Combines Syneos’ data collection and research services with Aetion Evidence Platform to generate evidence through patient data curation and real-world data.

  08.04.21
  

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• Breaking News | Clinical Trials | Drug Development | Industry News | Information Technology
  

  Almac, THREAD to Integrate Technologies for Clinical Trials

  Integrating technology platforms aims to provide sponsors and CROs with a full range of tools designed to reduce the risk of trial delays.

  07.28.21
  

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• Breaking News | Clinical Trials | Industry News | Information Technology
  

  WCG Acquires eClinical Provider VeraSci

  Aims to address growing demand for scientific and technology solutions for remote data capture, hybrid virtual studies and decentralized clinical trials.

  07.26.21
  

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• Clinical Trials | CRO News | Information Technology | Reader Showcase
  

  Quanticate Launches Updated Remote Source Data Verification Platform

  Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location

  07.19.21
  

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• Breaking News | Clinical Trials | Industry News | Information Technology
  

  Calyx Opens U.S. HQ Near Research Triangle Park

  RTP-based headquarters established to meet growing needs for eClinical and regulatory services.

  07.19.21
  

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• Clinical Trials | Information Technology | Reader Showcase
  

  Almac Offers Expedited IRT Solutions for COVID-19 Trials

  Launches the expedited deployment and support of multiple Interactive Response Technology (IRT) solutions in support of COVID-19 treatments

  07.16.21
  

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• Breaking News | Clinical Trials | Industry News | Information Technology | Logistics
  

  UPS Healthcare, THREAD Partner on Decentralized Clinical Trial Platform

  Brings together THREAD's digital platform and Marken's clinical trial logistics services to create a single seamless workflow for clients and patients.

  07.15.21
  

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• Breaking News | Clinical Trials | Industry News | Information Technology
  

  Medable Opens EMEA HQ in Dublin

  Expands European presence to grow market for decentralized clinical trials.

  07.15.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News | Parenterals
  

  Batavia Manufactures IAVI’s Lassa Fever Vax Candidate

  Uses innovative 'scale-X' bioreactor to support Phase I clinical trials.

  07.14.21
  

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• Breaking News | Clinical Trials | Collaborations & Alliances | Industry News | Information Technology
  

  CMIC and Lokavant Partner to Deploy Clinical Trial Intelligence Platform

  Enter first phase of multi-year partnership to deploy predictive analytics platform for monitoring and management of clinical trials in Asia-Pacific.

  06.29.21
  

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• Clinical Trials | Information Technology
  

  The Power and Promise of Decentralized Trials

  Clinical researchers turned to a range of digital solutions to address the effects of the COVID-19 pandemic on trials.

  Derk Arts, CEO, Castor 06.25.21
  

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• Breaking News | Clinical Trials | CRO News
  

  Syneos Expands Decentralized Trial Capabilities

  Aims to accelerate decentralized clinical trial delivery through collaboration with site sponsors.

  06.22.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development | Trials & Filings
  

  Novavax COVID-19 Vax is 90% Effective in Phase 3 Trial

  NVX-CoV2373 demonstrates 100% protection against moderate and severe disease, 90% efficacy overall, and met the primary endpoint.

  06.14.21
  

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• Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments
  

  Enteris BioPharma Receives $10M Milestone from Cara Therapeutics

  Third milestone payment related to the development of Oral KORSUVA.

  06.11.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Inspections | Process Validation | Risk Management
  

  Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

  Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.

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• Clinical Trials | CRO News | Industry News | Information Technology
  

  Bioclinica Adds eConsent to EDC Platform

  New electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote interactions.

  Kristin Brooks 06.08.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
  

  INOVIO, Advaccine Expand COVID Vax Alliance

  To jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 INNOVATE trial evaluating INO-4800 in a two-dose regimen.

  Kristin Brooks 06.08.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials
  

  Gene Therapy Trials

  Answering critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.

  April Marquick, Cell and Gene Therapy Expert, Premier Research 06.07.21
  

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• Clinical Trials
  

  Waving Goodbye to Human Clinical Trials in a Post-COVID Landscape

  Exploring the untapped potential presented by current biowaiver regulations.

  Jaleel Shujath and Rao Mukkavilli, Absorption Systems 06.07.21
  

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• Clinical Trials | CRO News | Drug Development | Information Technology
  

  Driving Efficiencies in Today’s Complex Trials

  Murray Aitken of IQVIA discusses CRO market trends, post-pandemic opportunities, and leveraging tech-enabled services and capabilities.

  Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 06.03.21
  

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• Clinical Trials | Drug Development
  

  The Future is Decentralized: What This Means for Clinical Trial Sites

  Benefits for research sites and how to prepare for decentralized trials.

  Marc Leighton, Vice President of Product at Florence Healthcare 06.02.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Drug Development
  

  Gene Therapy Trials

  Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.

  April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21
  

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• Clinical Trials | Drug Development | Information Technology
  

  Clinical Development Trends

  Digital modernization, decentralized trials, and advanced therapies drive outsourcing of clinical trials.

  Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 05.25.21
  

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• Breaking News | Clinical Trials | CRO News
  

  Emmes Acquires Orphan Reach

  Establishes Emmes as an industry leader in clinical research for orphan and rare diseases.

  Kristin Brooks 05.12.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
  

  INOVIO’s DNA COVID Vax Achieves Positive Results

  Phase 2 clinical trial shows INO-4800 was generally safe, well-tolerated and immunogenic in all studied age groups.

  Kristin Brooks 05.10.21
  

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• Clinical Trials | Logistics | Supply Chain
  

  LabConnect, Cryoport Partner to Support Triumvira Trial Logistics

  Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.

  Kristin Brooks, Contract Pharma 05.06.21
  

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• Clinical Trial Materials | Cold Chain Management | Facilities | Logistics | Supply Chain
  

  Expediting Clinical Trials

  Mitigate potential delays while awaiting IND approval with a Pre-IND strategy.

  Contract Pharma Staff

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• Analytical Services | Clinical Trials | Information Technology
  

  Implications of COVID-19 on Statistical Design and Analyses of Clinical Studies

  A look at the challenges and risks to statistical integrity and how they can be mitigated.

  Tim Victor, Head of Biostatistics, Clinical Research Services, ICON plc 05.05.21
  

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• Breaking News | Clinical Trials | CRO News | Information Technology
  

  Syneos, Komodo Health Expand Data App Alliance

  Leveraging Komodo’s Healthcare Map, Syneos aims to better analyze clinical, real-world, and commercial data.

  Kristin Brooks 05.04.21
  

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• Clinical Trials | Information Technology | Promotions & Moves
  

  Clinical Ink Adds Executives

  CCO Chris Crucitti, COO Brian Donahue, and VP Project Operations Bill Barrasso to manage eSource platforms.

  Kristin Brooks 05.04.21
  

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• Breaking News | Clinical Trials | Drug Development | Industry News
  

  Pfizer Acquires Amplyx Pharmaceuticals

  Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001).

  Tim Wright, Editor, Contract Pharma 04.29.21
  

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• Clinical Trials | CRO News | Information Technology
  

  PPD, Science 37 Partner to Advance Decentralized Trials

  PPD will leverage Science 37's DCT SaaS-based technology platform to design, build, test, implement and execute digital trials.

  Kristin Brooks 04.28.21
  

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• Clinical Trials | CRO News | Information Technology
  

  Syneos, Medable Partner for New Decentralized Capabilities

  Aims to increase clinical trial diversity and improve patient access and experiences with fit-for-purpose decentralized digital solution.

  Kristin Brooks 04.22.21
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings
  

  Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data

  VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.

  Kristin Brooks 04.22.21
  

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• Clinical Trials | R&D | Regulatory Affairs
  

  Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance

  Learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance in this webinar on May 13.

  04.22.21
  

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• Clinical Trials
  

  Decentralized Clinical Trials: The 101 on Digital Health Technologies (DHTs)

  The huge uptick in decentralized trials this past year has greatly increased the use of digital health technologies (DHTs).

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• Breaking News | Clinical Trials | Drug Development | Trials & Filings
  

  FDA Accepts Airway Therapeutics’ IND for COVID Treatment

  To initiate a Phase 1b trial to confirm the feasibility of intratracheal administrations of AT-100 and its beneficial safety and tolerability profile.

  Kristin Brooks 04.12.21
  

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• Breaking News | Clinical Trials | CRO News | Industry News
  

  Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ

  Offers full-service human absorption, metabolism, and excretion (hAME) studies with radiolabeled compounds.

  Tim Wright, Editor, Contract Pharma 04.09.21
  

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• Breaking News | Clinical Trials | CRO News
  

  Merck KGaA Selects PRA’s Remote Patient Monitoring Platform

  Adding layer of technology to HGH treatments aims to facilitate better patient compliance.

  Kristin Brooks 04.08.21
  

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• Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
  

  Alkermes, Merck Enter Clinical Trial and Supply Agreement

  To evaluate nemvaleukin alfa in combination with Keytruda in patients with platinum-resistant ovarian cancer.

  Tim Wright, Editor, Contract Pharma 04.07.21
  

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• Breaking News | Clinical Trials | Drug Development | Industry News
  

  Sound Pharmaceuticals Receives $3.1M NIH Grant for COVID Treatment

  To support the testing of SPI-1005 in two Phase 2 clinical trials for the treatment of COVID-19.

  Kristin Brooks 04.06.21
  

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• Breaking News | Clinical Trials | CRO News | Drug Development
  

  Moleculin Selects IQVIA Biotech to Advance COVID Treatment

  IQVIA to manage the company's effort to begin potential clinical trials of WP1122 for the treatment of COVID-19.

  Kristin Brooks 04.06.21
  

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• Clinical Trials | Drug Development | QA/QC
  

  RBQM Comes of Age: COVID as a Catalyst for Change

  Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.

  Online Exclusives Kristin Brooks, Managing Editor 04.01.21
  

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• Clinical Trials | CRO News | Information Technology
  

  PPD, Clinical Ink Partner on Near Real-Time Access to Endpoint Data

  Jointly develop systemic lupus erythematosus assessment review process to enhance data quality and research site personnel experiences and efficiencies.

  Kristin Brooks 03.24.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Trials & Filings
  

  CureVac Expands Late-stage Trials of COVID Vax Candidate

  Further analysis to determine efficacy of the vaccine candidate for new virus variants.

  Krisitn Brooks 03.22.21
  

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• Clinical Trials | Drug Development
  

  Regulatory Practices in a Post-Pandemic World

  Envisioning the new normal for clinical development.

  Dr. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 03.22.21
  

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• Breaking News | Clinical Trials | Drug Development | Trials & Filings
  

  Gilead, Novo Nordisk Expand NASH Alliance

  Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.

  Kristin Brooks 03.18.21
  

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• Breaking News | Clinical Trials | Drug Development | Trials & Filings
  

  Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy

  Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.

  Kristin Brooks 03.16.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
  

  Novavax Confirms Efficacy Against Original and Variant COVID-19 Strains

  Final analysis of NVX–CoV2373 in UK trial confirms 96% efficacy against original strain of COVID-19 and 86.3% against the B.1.1.7 variant.

  Kristin Brooks 03.12.21
  

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• Clinical Trials | Information Technology
  

  The Evolution of Clinical Research Technology to Support Remote Collaboration

  Pioneering change with technology advancements that yield high reward with tolerable risk.

  Angela Gill Nelms, COO for Florence Healthcare 03.11.21
  

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