MAIA R&D Activities: We have a twenty-year successful experience in registering novel pharmaceuticals an can help you in several aspects of Pre-clinical and Clinical development. Whether you are preparing a First-in-Man, running a pivotal Phase III study or gearing up for a full Marketing Authorization, MAIA R&D can help you. We assist start-up companies with preclinical and clinical strategy and development plans. We help Biotech and Pharmaceutical Companies with all clinical documents authoring and review (Protocols, Study Reports, Summaries, Narratives).
 
 

 
 
Documents
 
Performance
 
Strategies
 
Technologies
Authoring and review of R&D Documents, Trial Protocols, Development Plans, Study Reports, Written Summaries, Investigator's Brochures.
Communication with Health Authorities, Ethics Committees, IRBs.Translations.
 
Clinical Trials Performance management. Metrics definition, Key Performance Indicators, dashboards and reports. Trial management, case adjudication management.
 

Pre-clinical and Clinical strategy plans, Clinical development plans. Quality documentation, Standard Operating Procedures, Standards, Policies.

 
Assessment, selection and deployment of enabling technologies, Electronic Document Management, Structured Content Authoring, Clinical Trials Tracking Systems, eTMF, e-adjudication.
   © Copyright MAIA Consulting 2013