Therapeutics Inc.’s clinical operations
team is responsible for initiating and managing clinical studies
prescribed by the clinical development group’s “General
Investigational Plan.” We have experience providing a broad
spectrum of clinical services, including: Phase I safety or pharmacokinetic
studies, Phase II dose-ranging studies, Phase III pivotal studies
for registration and Phase IV post-marketing studies. You can
be confident that Therapeutics will work with you to develop an
initial investigational plan, including timelines and action items
to ensure that milestones are met.
Services provided by
the clinical operations group include:
Clinical Development Project Management
- Develop project timelines and budgets.
- Track and manage weekly project progress.
- Develop and maintain sponsor communications to ensure sponsor awareness of project progress.
- Set up and maintain project files.
Medical Monitoring
- 24 hour/7 day per week medical monitoring.
- Site support for protocol subject qualification and medical needs.
- Experienced SAE handling and processing.
Site Qualification and Setup
- Conduct qualification visits.
- Develop and ship site regulatory binders.
- Generate, collect and review regulatory documents.
- Collect IRB documents.
- Oversee shipment of clinical supplies, drugs, devices.
- Develop screening and enrollment logs.
Investigator Meetings
- Organize and plan investigator meetings.
- Conduct investigator meetings.
Site Initiation, Monitoring and Close Out
- Conduct initiation visits.
- Monitor subject enrollment.
- Develop multimedia advertising templates.
- Conduct routine monitoring visits.
- Perform site audits.
- Prepare project newsletters.
- Oversee return shipment of clinical supplies, drugs, devices.
Medical Writing
- Create expert reports/summaries.
- Generate clinical study reports
Regulatory Submissions & Management
- Prepare, submit and maintain INDs, NDAs, BLAs, CTDs, IDEs,
PMAs, 510(k)s.
