Clinical Research Services
BioFicher offers a robust suite of clinical research services for your Phase I-IV clinical trials, registries, and other clinical research Phase I-IV initiatives.
Statistical design and analysis
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Protocol design and pre-study feasibility
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Statistical analysis plan
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Central statistical monitoring
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Data and Safety Monitoring Board support
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Reporting and manuscript preparation. Visit Biostatistics
Protocol development and data management
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Protocol document review for consistency, completeness and clarity
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Creation of electronic Case Report Forms (eCRFs)
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Deployment of electronic data capture system
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Site support, data cleaning and quality control processes to ensure data integrity
Investigator, site and patient services
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Site identification, recruiting, selection, activation, and monitoring
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Site regulatory compliance monitoring
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Patient recruitment, screening, registration, blinding and management
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Electronic patient reported outcomes (ePRO) data collection and support services
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Site auditing to ensure study progress
Safety and Pharmacovigilance services
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Safety monitoring using BioF’ Advantage eClinical
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Adverse Event (AE) and Serious Adverse Event (SAE) reporting on site and country levels
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Case processing
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SAE narrative writing and submissions
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Aggregate safety reporting, event trend and signal detection services
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Adverse event coding according to Medical Dictionary for Regulatory Activities (MedDRA)
Regulatory Affairs Support
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Country and site-level regulatory authority applications
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Investigational New Drug (IND) and Investigational Device Exemption (IDE) submissions
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Maintenance of Biologics License Applications (BLAs), IND applications and Trial Master Files (TMFs)
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Medical writing and Clinical Study Report compilation
Advantage eClinical technologies
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Suite of clinical data collection, management and analysis tools
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Electronic data capture (EDC) of case report forms and other study data
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Patient randomization and blinding
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Inventory management/tracking of specimens and shipments
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Pharmacovigilance monitoring and management
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Electronic patient reported outcomes (ePRO) MORE
Medical writing
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Protocols for both interventional and non-interventional trials or investigations
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Informed consent forms
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Data management plans, statistical analysis plans, monitoring plans, site operational manuals, etc
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Clinical study reports: interventional and non-interventional trials
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Product or disease registries
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Manuscripts, posters, and presentations for the trial result publication
Statistical design and analysis
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Protocol document review for consistency, completeness and clarity
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Creation of electronic Case Report Forms (eCRFs)
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Deployment of electronic data capture system
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Site support, data cleaning and quality control processes to ensure data integrity
Quality Assurance
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Auditing of study data, sites, laboratories, 3rd party vendors, and Contract Research Organizations (CROs) to ensure operations follow established procedures
Our Story
Bioficher is focused on helping small and mid-sized pharmaceutical and biotech companies navigate the clinical trial process from strategy to approval so breakthrough ideas can help patients everywhere.
Our 6+ years of worldwide experience in trial design and execution, complex therapeutic areas, and challenging indications make us a valuable partner and trusted extension of your team’s capabilities.
We offer global experience purpose-built for your clinical trial needs: