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TrialScope

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Clinical Trial Disclosure Management: Build vs. Buy

Because software development is our core competency, TrialScope continues to make a significant investment in our technology. We employ agile methodologies to ensure that we can maintain a continuing level of responsiveness as disclosure requirements evolve across registries and regions.
Clinical Trial Disclosure Management: Build vs. Buy
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News and Press Releases

NDA Group welcomes Marianne Scheel Fjording, Ph.D. to the NDA Advisory Board adding essential expertise in bioanalysis and immunogenicity assessment to the team

Stockholm, Sweden 7 March 2023 Life Science Newswire NDA Group is thrilled to announce the expansion of their Advisory Board with the appointment of Marianne Scheel Fjording, Ph.D. Marianne is a highly experienced expert in regulated bioanalysis and immunogenicity, with an emphasis on bioanalytical method development and validation of advanced biologics. She has a wealth of experience in the development of gene and cell therapies, engineered proteins, therapeutic antibodies, and derivatives, as well as biosimilars.
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White Papers

Conveying Medical Guidance in Clinical Trials A Survey

Europital Medical Consultancy

With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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Industry Events

The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023)

12-13 June 2023, Hilton Geneva Hotel & Conference Centre, Geneva, Switzerland

The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023) gathers top-level management from pharmaceutical companies of manufacturing, primary and secondary packaging, purchasing, and supply chain and procurement sectors, CMOs and CDMOs leaders, heads from government and institution on 12-13, June, 2023 in Geneva, Switzerland.
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