- Biostatistics: collect and analyze numerical data from biomedical experimentation and clinical trials.
- Electronic Data Capture
- Medical Lead
- Medical Writing
- Protocol Development
- Our clinical data managers are involved at all stages to ensure that data is reliable and of the highest quality, from Case Report Form (CRF) Design, to data validation to database lock.
- Our project managers have a wealth of industry experience that enables them to see the end from the beginning, then build and lead strong teams towards the same goal.
Statistical Programming and Analysis
- Our statistical programmers assist with study design and protocol development, ensure adequate sample size and develop and implement comprehensive statistical analysis and review plans.
- As we pattern our processes and recruitment strategies to address the charge of the FDA Safety and Innovation Act (FDASIA), we will be able to generate better quality data that can be trusted across ethnic populations with new and existing medications and therapies. We focus on:
- Patient Recruitment
- Patient Retention
- Grassroots and Targeted Media Strategies
Drug Safety and Pharmacovigilance
- Our safety officers understand the importance of reporting and processing adverse events and serious adverse events and are on-call around the clock. They also provide Early Development Safety & Medical Services and Post-Approval Product Support Services.
Management of Clinical Trial Samples
- We will set up the required SOPs, train study personnel and oversee sample management and preservation.
Medical and Clinical Trial Monitoring
- Our medical and clinical trial monitors are experienced in multiple therapeutic areas and based strategically to help save on travel costs. They understand the importance of meeting metrics.
- We develop and manage a comprehensive Quality Management Program, which includes Quality Assurance and Quality Control processes as well as a Corrective Action and Preventive Action (CAPA) Program. We also provide strategic direction to prepare for possible FDA and EMA audits.
Our regulatory specialists understand and abide by the letter and spirit of the law regarding required regulatory submissions. We have developed our regulatory processes to be like a well-oiled machine, thereby creating a smooth flow when preparing, filing or maintaining drug and medical device clinical trial applications.