Life Sciences
Acquerant provides a range of services, including Clinical Operations, Drug Safety / Pharmacovigilance, CDISC-compliant eSubmission, Medical Writing, Data Management, Biostatistics, Statistical Programming services to pharmaceutical, biotechnology, and medical device industries worldwide.
Clinical Operations
From start-up to close-out, our highly skilled clinical operations team ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsors.
Services include clinical monitoring, project management, clinical research, late phase (phase IV) research, quality control and quality assurance.
Broad coverage of therapeutic areas, e.g., specialty drugs, medical device, vaccine, medical technology, etc.
Execution of global multicenter projects with speed and quality.
Medical Affairs and Medical Writing
Acquerant will support in Clinical Study Protocols, Investigator Brochures, Clinical Study Reports, Subject Nerratives, IND Annual Safety Reports, Manuscripts, Abstracts, or Slides for Posters and Presentations, Benefit/risk assessment reports, and more.
Pharmacovigilance
Our physicians will help you in following areas:
– Aggregate Reporting
– Risk Management
– Signal Detection & Risk Management
– SDEA Management
– Literature Management
– Medical Information Call Center (MICC)
– Clinical Medical Writing
– Identification of Medical Products (IDMP)
– Medical Translation services
– Develop custom tools, plug-ins and DB solutions for client specific needs
– Safety system configuration
Data Management and Statistical Analysis
Our data management team has extensive experience in the following areas:
– Review of Protocols, Case Report Forms, Reports and SAS output, etc.
– Development and maintenance of Data Management Plan (DMP) compliant to study design and requirements
– Development of Case Report Form (CRF)
– Development of database (DB)
– Maintenance/tracking of EDC user management
Ensuring compliance with good clinical programming practices our biostatisticians will support you in:
– Development of specifications for datasets analysis in consultation with Biostatistician
– SAS Programming
– Producing TLGs according to SAP