We're innovative, engaging, and driven to advance medical breakthroughs.

Biotech, medical devices manufacturers and pharmaceutical companies develop products that impact patient’s lives – and the lives of family and caretakers. Many drugs have limited impact on efficacy and safety versus drugs already on the market. As we evolve as a society of drug developers and caretakers, we want more for patients. That’s why basic medical expertise, plus advanced therapeutic expertise are so important. Breakthrough treatments for illnesses are more and more grounded in advanced research.

Our team is made up of 400+ innovative and engaging healthcare professionals with senior management experience in pharma. Advanced therapy medical products require special preparation and review of clinical documentation, advanced management of orphan drug designation applications to the FDA and EMA and extra support on the design of early clinical trials and efficient operations.

And now, first-in-human (FIH) studies have more deviations, such as patients receiving a completely novel drug or a combination of new and approved drugs. Or specific patients being exposed, such as the elderly. PSNResearch has devoted considerable time and resources to the development of a proprietary process model specifically tailored to FIH studies.

Medical advisors located in eight countries consult on your clinical development plan:

  • • Interpreting market access studies
  • • Writing protocols and SOPs
  • • Understanding investigational review processes
  • • Writing applications, study reports, and safety documents

We use unique and adaptive approaches to clinical research services. We know how to identify biomarkers to determine clinical endpoints, as early in the clinical process as possible, to ensure successful ongoing protocol design.

Medical Writing

  • Investigational Medicinal Product Dossier (IMPD)
  • CER reports
  • Region-specific Module 1 documents
  • Scientific manuscripts
  • Pharmacovigilance (Preparation of RMPs, DSURs, PBRERs and annual safety reports)
  • Clinical trial applications
  • Clinical study reports
  • Efficacy and safety response documents
  • Protocols and protocol amendments

Medical Documents

  • Clinical Development Plan
  • Market Access Studies
  •  Agency meeting briefings
  • Protocols and SOPs
  • DSMB reports
  • Environmental assessments
  • IRB communications
  • Medical monitoring review
  • Reporting to health authorities
  • Scientific abstracts, manuscripts, posters, conference reports
  • Scientific Advice guidance to Regulatory Agencies (SA)

Investigator and Patient

  • Case Report Form (CRF) and patient diaries
  • Patient information brochures
  • Investigator brochures
  • Informed consent