Services for Sponsors and CROs
Apex Clinical Trials, LLC (Apex) is a Trial Management Organization (TMO):
Conducting Phase II-IV, Inpatient and Outpatient Trials in:
- all medical and psychiatric (CNS) indications
- geriatric, adult, adolescent patient populations
- the United States
- European Union and Other Countries – Coming Soon
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With Centralized Management of:
- Independent investigators and Investigator Sites
- CDA and Feasibility
- Budget and Contracts
- Regulatory Services
- Patient Recruitment
- Trial Management
- Standard Operating Procedures (SOP’s)
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With Extensive Experience in:
- Conducting Safety/Efficacy Studies
- Interactive Voice Response Systems (IVRS)
- Electronic Data Capture (EDC) Technology
- FDA, ICH and GCP Guidelines
- HIPAA Regulations and Security
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Patient Recruitment:
- one of the high enrollers in most studies to date
- uses a professional patient recruitment organization
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Services for Investigators
Apex offers new studies to investigators with centralized CDA, feasibility, budget, contracts, regulatory submission to sponsors & CRO’s globally including complete patient recruitment. We also provide study coordinators and support infrastructure set up.
Apex provides the Investigator/Investigator Site with the following services with 24/7 help line:
- Complete study management
- New clinical trials
- Study coordinator as required
- Centralized CDA & feasibility submissions and management
- Pre-study site visit (PSSV) package, scheduling and management
- Centralized budget & contracts negotiation and management
- Centralized regulatory affairs submissions and management
- Site initiation visit scheduling and management
- Complete patient recruitment with patients phone screened and scheduled for each study
- Monitor visits scheduling and management
- Close-out visit scheduling and management
- Payment to principal investigator/investigator site with various options.
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Services
