CompleWare Corporation offers contract research organization (CRO) services to ensure that all aspects of your clinical trial study are properly managed.
- Acute and Environmental Allergy Studies
- Case Report Form (CRF) (Design, Programming, Validation, Deployment, Tracking)
- Central Laboratory Services (Selection, Supervision, Integration)
- Central Study Master File (Establishment, Maintenance)
- Clinical Laboratory Data, Integration
- Clinical Study Report (CSR) (Writing and Review, Integration of Safety and Efficacy Data)
- Computer Programming
- Contract Negotiations (Legal Document Development, Contracts and Budgets, Confidential Disclosure Agreements)
- Data Clarification
- Data Management (Data Review According to Specification in Data Management Plan, Transmission, Submission)
- Data Management Plan (DMP) (Including Edit Checks, Batch Procedures)
- Data Visualization (Online)
- Database (Programming, Verification, Validation)
- Disposition Coding
- Document (Management, Imaging)
- Drug Accountability
- Drug Safety
- Electrocardiograms (ECGs) (Collection, Central Review)
- Essential Document (Management)
- Help Desk Support
- Image Analysis (Radiology)
- Investigational Site or Site Network (Recruitment, Evaluation, Support)
- Investigator Meeting (Planning, Coordination)
- Investigator Payments
- Investigator Site Management
- IRB Document (Development, Review, Document Handling)
- MedDRA Coding
- Medical and Report Writing
- Monitor Auditing
- Monitoring (Qualification Visits, Initiation Visits, Routine Visits, Closeout Visits)
- Monitoring Plan (MP) (Development, Deployment)
- Monitoring Reports (Generation, Review, Submission)
- Patient Reported Outcomes (PRO) (Development, Collection, Maintenance, Reporting)
- Personnel training (CRAs, CRCs, Investigators, Oversight)
- Pharmacoeconomic Analyses
- Pharmacokinetic Analyses
- Post-study Audits
- Pre-study Audits
- Project Management
- Project Management Plan (PMP) (Development, Deployment)
- Protocol and Clinical Trial Design (Development, Review, Implementation)
- Pulmonary Diagnostics (Collection, Central Review)
- Quality Assurance and Auditing
- Quality of Life Instruments Testing
- Query Generation and Resolution
- Randomization (Central)
- Regulatory Document (Processing)
- Regulatory Submissions
- Requests for Change of Data (Processing, Review, Implementation, Notification, Documentation)
- Review of Clinical Data
- Shipping
- Site (Selection, Training, Management, Payment)
- Site and Subcontractor (Oversight)
- Software (Development, Evaluation)
- Spirometry/Challenge (Collection, Central Review)
- Statistical Analyses (Including Listings, Meta-Analyses, Reporting)
- Statistical Analysis Plan (SAP) (Development, Review, Implementation)
- Study Document (Assembling, Archiving)
- Study FAQs (Development, Deployment, Maintenance)
- Study Initiation (CDAs, Contracts, Distribution, Collection of Essential Documents)
- Supplies
- Training (Including Document Development, Printing, Deployment for Sponsor, Monitors, Sites, Subjects)
- Translations (Electronic Diaries, CRFs)
