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
- 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
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