Tag: 临床透明度和信息披露
法规和医学撰写
High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.
Changing the Game in Oncology Drug Development and Patient Access
Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.
Certara’s Best of the Blog 2017
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results
In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results.
人工智能技术如何改变法规撰写
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with … Continued
Navigating EMA Policy 0070—How Do We Ensure Compliance?
Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
Certara’s Synchrogenix Division and PleaseTech Partner to Streamline Document Redaction Services
PRINCETON, NJ – Aug. 4, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that its regulatory and medical consultancy, Synchrogenix, is partnering with document co-authoring and collaborative review specialist PleaseTech Ltd. to deliver a seamless regulatory document creation process.
Updates to EMA Policy 70 Anyone Working in Clinical Transparency and Disclosure Should Know
During this presentation, Lora Killian, Synchrogenix Director of Transparency and Disclosure, discussed complications caused by the requirements outlined in the guidance document, EMA Policy 70, and proposed some solutions.
A New Model to Meet BioPharm Transparency Mandates and Engage Participants as Clinical Research Partners
This webinar discussed best practices for sharing plain language trial results as a foundation for helping ensure that patients who give the gift of study participation have the opportunity to understand their contribution to advancing medical science.
