Premier Research has developed and implemented a functional sourcing approach over the past seven years allowing sponsors to leverage our expertise within clinical research and the international depth of our resource pool with oversight from subject matter experts and senior management.
Functional Sourcing Models
We offer different sourcing models based on your requirements:
- Outsourcing: Resource, based at a Premier Research office or regionally, is assigned to sponsor who provides work delegation, project management, and Clinical Data Management Systems (CDMS)
- Insourcing: Resource, based at sponsor location, is assigned to sponsor who provides work delegation, project management, and CDMS
- Offshore Solution: Experienced English speaking professional based at a Premier Research office in Eastern Europe, provides data operations services, including data management, database programming, lab data loading, and clinical programming
- Hybrid Solution: A mix of multiple outsourcing models are utilized to execute a clinical research function
- Consulting Projects: Requests that are not met through core operating groups including database hosting, site data entry, project management consulting, data management report development, remote medical coding, database and CTMS administration, systems validation, and more
- Complete or partial sourcing customized to your needs and implemented to ensure seamless integration with your team
- Infrastructure in place to either connect directly to your data management system or to host your trials/data on our validated systems
- Experienced staff with expertise in Oracle Clinical, Oracle Clinical RDC, ClinTrial, Inform, Medidata, and more
- Ability to provide additional resources when, and for as long as, needed to meet all critical timelines
Proven Experience
We have experience assisting many different companies including:
- Growing biotechs that may not have sufficient in-house resources
- Sponsors interested in maintaining a low overall head count while still requiring clinical research services
- Companies seeking to improve financial statements in advance of an acquisition or for sponsors in the midst of an acquisition
- Sponsors focusing on their core product development
- Clinical Trial Management
- Clinical Monitoring
- Medical Monitoring
- Pharmacovigilance
- Data Management
- Biostatistics
- Medical Writing
- Quality Assurance
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