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Proof of concept trials

PROOF OF CONCEPT TRIALS

proof of concept trials

ARENSIA delivers high degree of scientific and logistical expertise for Phase I/Ib/IIa and PROOF OF CONCEPT patient studies.

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PHASE I SPECIAL POPULATIONS

phase i special populations

ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired patients.

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REGULATORY PROCESS

regulatory process

ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

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ARENSIA Spotlight Session, November 07th, Boston, MA

HOME · NEWS · ARENSIA SPOTLIGHT SESSION, NOVEMBER 07TH, BOSTON, MA

We are pleased to announce ARENSIA Spotlight Session "Innovative Strategies to Achieve First Efficacy Data / Proof-of-Concept in Record Time", which will take place on 7th November 2017 in Boston, MA.

In today's fast-changing world, to stay competitive means to be innovative and open to embrace new approaches. Industry is facing time-pressing competition when fast movement through exploratory clinical phase is posing great challenges. Early go/no-go decisions have become critical. This is in contrast to dropping efficiency of clinical operations, constantly increasing complexity of study protocols and skyrocketing costs.

Industry thought leaders will gather for a one-day series of round table discussions to exchange their vision of paradigm shifts in early clinical development that are already underway and yet to happen. The focus will be on practical aspects of implementation of innovative approaches to achieve Proof of Concept results in record time. We will share best practices and real-life case studies, exploring them from different perspectives – regulatory, sponsor, clinical site and patient.

Attendees will be able to address these issues and leave the day better informed on how to:

  • Develop an efficient strategy to Proof of Concept (First-in-Man -> First-in-Patient): classical approach vs. "umbrella" protocols
  • Overcome challenges in execution of exploratory protocols: from feasibility stage to successful patient enrolment in Phase 1b/2a studies. Case studies from oncology, immunology and infectious diseases.
  • Balance scientific/business interests & regulatory requirements
  • Navigate in the new EMA legislation on Phase 1 clinical trials following the incident in France

We are happy to invite you to join us in San Francisco. Please contact us at info(at)arensia-em.com for more details.

07.11.2017