Medical Writing

 

Therapeutic Area Experience
Focus on NIS
Regulatory Trials
e-CRF
QA Activities
Medical Writing
Phv in Clinical Trials

GB Pharma employs a team of experienced Medical Writers who can give support at all stages of product development:

  • Preparation of study protocols
  • Study reports
  • Posters
  • Manuscripts for publication
  • Submission of regulatory documents (including e-CTD).

Beyond the high level of know-how for MW projects, GB Pharma can count on further support of a network of experts in medical, scientific and technical areas.

Management and regulatory documents for clinical trials:

  • Protocols for clinical trials
  • Reports of clinical trials, with the help of experts in specific therapeutic areas (grouping, writing data and writing the results in English and Italian, statistical analysis)
  • Drug Safety Summaries (Summary data on efficacy and safety)
  • Final Study Reports
  • Investigator’s Brochures (analysis of literature, publications of the last 10 years, medical reviews, with the use of DB as EMBASE, PubMed)
  • Clinical Overview and Clinical Expert Statement Form 2.5 CTD
  • Brochures.

Medical Devices

GB Pharma has developed an extensive experience in managing medical devices trials within different therapeutic areas:
  • ICD in patients with atrial fibrillation
  • Drug eluting stent in the treatment of coronary arthery lesions
  • Safety and efficacy of stent in acute miocardial failure in patients with angioplastic
  • Natural knee in patients with arthritis, ostheo-arthritis
  • Implantable cardioverter defibrillator (ICD) in patient at sudden death risk
  • Cardiac resynchronization therapy-defibrillator (CRT-D)
  • Phrenic nerve stimulator.
  • Closed Loop Stimulation (CLS) in tilt-induced cardio-inhibitory reflex syncope.
  • Study verified by ILR in patients with unexplained syncope

Marketing Documents

> Manuscripts for publication

> Literature review

> Product Monographs

> Advertising materials

> Articles in professional journals

> Items for print to the public.