Clinical r&d services subpage

MEDICAL DEVICE

Medical device from development to market:

Pharmahungary Group is uniquely positioned on medical device and combination product clinical trials.

  • Our preclinical team can be your partner in preclinical development of your medical device and combination products
  • Excellent knowledge of medical device and drug-device combination regulations and regulatory and ethics submission requirements
  • Consulting in regulatory and ethics committee submission
  • Developing a comprehensive design of clinical trials with medical devices
  • Feasibility studies, monitoring, site management, and project management from study start-up to closure
  • Utilizing optimum sites and investigators
  • Meeting aggressive timelines in clinical trials with medical devices
  • Medical device registration services
  • Vigilance MEDDEV

Selection of reference medical device studies:

  • Osteoarthritis medical device clinical trial for CE mark
  • Angioplasty medical device clinical trial for CE mark
  • Malignant melanoma medical device with CE mark clinical trial
  • Heart failure study with medical device for CE mark
  • Neurointervention, brain aneurysm medical device postmarketing trials
  • Investigator Initiated Trial in cardiology: Ischemic postconditioning
  • In Vitro Diagnostic – feasibility performance evaluation: a miniaturized electrochemical biosensor is used for colon cancer screening
  • Pressure controlled intermittent coronary sinus occlusion in ACS
  • Investigator Initiated Trial in psychiatry: The intrusive mental contents neurocognitive mechanisms of psychiatric disorders
  • Investigator Initiatd Trial in cardiology: biventricularis upgrade; ICD-CRT-D devices

INVESTIGATOR INITIATED TRIALS

Investigator initiated clinical trials represent an increasing and extremely important portion of medical research, especially in development of medical devices.

Since 2010 the preclinical and clinical staff of Pharmahungary Group has been working together with manufacturers, research professionals to develop new collaboration structures in this cutting edge field.

Benefits of investigator initiated research trials:

  • For the manufacturer: first hand scientific innovation from research physicians, new devices reach patients faster, time and cost saving
  • For the research professional: opportunity to realize their scientific, medical innovations in the development of medical devices
  • For the patient: cutting edge medical devices/drug-device for improved quality of life

Planning, conducting and managing investigator initiated research trials in all indications, especially focusing on cardiovascular and neurointerventional therapeutic fields.

Selection of reference Investigator Initiated Trials:

  • Investigator Initiated Trial in cardiology: biventricularis upgrade; ICD-CRT-D devices
  • Investigator Initiated Trial in cardiology: Ischemic postconditioning
  • Investigator Initiated Trial in psychiatry: The neurocognitive mechanisms of intrusive mental contents of psychiatric disorders

NICHE TRIALS

We are the experts to turn your unfeasible study feasible

Pharmahungary is specialized in unique clinical trials that need sensitive patient population and therefore strong regulatory and scientific consulting.

Pharmahungary Group knows that every clinical trial is different and thus deserves a unique approach. Your drug, medical device or drug-device combination development process demands a concentrated, customized and well-executed clinical study from start-up to closure.

Our highly qualified, industry seasoned experts (board certified clinical pharmacologists) recognize that every partnership is different and find the best way to add value to your project. The main goal of Pharmahungary Group is to provide customized scientific and clinical trial management services to meet your clinical trial objectives and serve as your creative R&D team.

A current reference study: Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation: ClinicalTrials.gov Identifier: NCT01130636

For more information, please do not hesitate to contact us at businessdevelopment@pharmahungary.com

REGULATORY, ETHICS COMMITTEE

Pharmahungary Group routinely provides strategic advice and consulting for clinical trial submission to competent authorities and ethics committees.

Our medical writer and clinical monitoring experts guide you through the compilation of all necessary documents to adhere all regulatory formats. Our services include:

  • Dossier preparation, submission
  • Consulting, organizing meetings with competent authorities and ethics committees
  • Certified translating and back-translating clinical trials documentation

Our medical device and drug-device combination experts are able to provide you with full range of consulting and agency liaison services to secure product approval, facilitate fast and cost-effective market entry and ensure continued compliance throughout the life cycle of your drug, medical device and combination product.

Pharmahungary Group’s more than a decade-long experience with, and in-depth knowledge of, local and global regulations and regulatory guidelines is the key to your study success.

For more information on our regulatory and ethics committee services, please do not hesitate to contact us at businessdevelopment@pharmahungary.com

REGISTRATION

Pharmahungary Group is your ideal partner to ensure the success of your biopharmaceutical, food supplement, medical device, and combination product.

Our industry seasoned experts bring their diverse, interdisciplinary knowledge to serve you registering your product in Hungary, a member of the European Union.

  • Preparation of preclinical and clinical dossiers for product registration
  • Preparation of Patient Information Leaflets (PIL) and their readability testing, as well as Summary of Product Charasteristics (SmPC)
  • Rx to OTC switch

For more information on our registration and marketing services, please do not hesitate to contact us at businessdevelopment@pharmahungary.com

Megszakítás