IctalCare launches M1 Epilepsy Alarm

IctalCare’s success story results from our contribution to their clinical development process: protocol writing, monitoring, data management, statistics, and reporting.

Use of our proprietary clinical development methodology has resulted in this project achieving the final approval stage of the research process. A particularly challenging medical product (its software algorithms designed to filter out normal human physical activity and only alert when true epileptic episodes occur), our dedicated team helped IctalCare overcome obstacles that arose during the trial.

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Preferred Provider Status Achieved

Challenge: A specialty biopharmaceutical company targeting the therapeutic power of plasma for the treatment of chronic, life-altering diseases like hemophilia and immune deficiencies, contracted us to perform CRO services for two different Phase III studies. Regulatory requirements included an audit mid-way through the process.

We ensured that our strategic partner won preferred provider status after successfully completing an audit of protocol design, conduct, monitoring, data management, and quality assurance processes.

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FDA Approval for Monoclonal antibody CD20

Our contributions include:

  • First-in Human and pivotal clinical trials
  • eCTDsubmission to FDA
  • Oncologic Drug AdvisoryCommittee

Our achievements include:

  • No 483 findings
  • Positive vote during ODAC
  • FDA approval
  • Increased indications afterwards
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Cardiovascular drug released to new markets

PSNResearch performed reviews of preclinical and clinical documentation, preparation of re-positioning strategy based on available evidence, preparation of scientific publication and created medical and marketing training

Our client successfully launched the product in new markets (Russia, Turkey, Ukraine).

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