How to Successfully Conduct Overseas Clinical Trials as a Small-Medium Sized Biopharmaceutical Company

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Patient Recruitment & Retention, Emerging Market,
  • Monday, November 22, 2021

Amidst a constantly changing global clinical trial landscape, small-medium sized biopharmaceutical companies must take into consideration the global clinical trial (CT) industry and investment trends when entering new markets. In this webinar, the panelists will outline the top criteria and important factors for small-medium sized biopharma companies looking to expand their ROI and development outside of major markets, including industry market trends and opportunities for growth, as well as any translation or localization requirements needed to enter new markets.

The webinar will also discuss how language service providers (LSPs) can help sponsors of biopharmaceutical industry-sponsored clinical trials (BPCTs) leverage best practices to ensure all technical documentation, patient safety reports and data, and other important aspects are translated and compliant with relevant regulatory bodies. Dr. Vladimir Misik will also quantify the nature of CT industry investment, and predict which markets will see the most growth in the coming future.

Register for this webinar to learn more about clinical trial industry investment and market competitiveness and attractiveness.

Speakers

Dr. Vladimir Misik, LongTaal

Dr. Vladimir Misik, Partner & Founder, LongTaal

Dr. Vladimir Misik is the Partner and Founder of LongTaal, Partner and Co-founder of VIARES Academy, as well as a board member at SanaClis. With 30 years of biomedical R&D experience, Dr. Misik has held a range of previous roles within the industry and in academia, working as a VP and Head of Global Centralized Operations Center, Global Clinical Operations Leadership Team Member and Regional Head of CEE and MENA at Quintiles/IQVIA.

Dr. Misik has published extensively on various aspects of the globalization of industry clinical trials, contributed to oncology research at the National Cancer Institute in Bethesda, Maryland, as well as Cardiovascular Research at the George Washington University School of Medicine. Dr. Misik is an Editorial Board Member at Applied Clinical Research, Clinical Trials and Regulatory Affairs as well as a member of the DIA Global Core Committee for Clinical Research.

Message Presenter
Joshua Maislin, CSOFT

Joshua Maislin, Sr. Customer Success Manager, CSOFT Health Sciences

Joshua has worked to help pharmaceutical companies in their global efforts for over 15 years. He has focused specifically on helping companies translate and adapt patient-facing clinical trial material for a global patient population. He has a degree in Linguistics.

Message Presenter

Who Should Attend?

Managers and above at pharmaceutical, medical device and biotech companies with job functions including, but not limited to:

  • Clinical Trial Protocol Design
  • Clinical Operations
  • R&D
  • Regulatory Affairs
  • Patient Recruitment & Retention
  • Patient Engagement
  • Medical & Scientific Affairs
  • Market Access
  • Healthcare Diversity

What You Will Learn

Join this webinar to learn:

  1. What the current and future major clinical trial trends are
  2. Important clinical trial strategy questions sponsors of BPCTs should consider
  3. The importance of regulatory compliance and safety content translation
  4. How language service providers (LSPs) ensure translated content is accurate and effective

Xtalks Partner

CSOFT Health Sciences

CSOFT Health Sciences provides end-to-end medical translation services for all phases of the product lifecycle, from preclinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.

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