Our complete portfolio of services

 

Project Management

  • Sponsor Communication

  • Study Coordination

  • Manage Trial Status Reports

  • Timelines

  • Budgets

  • Training

  • Investigator Meetings

  • Resource Management

  • Vendor/Provider Management

  • Investigator Grant Management

  • Trial Master File

  • Patient Registration

  • Negotiate Investigator Contract & Budgets

  • Site Payment Admin

 

Site Management & Monitoring

  • Develop Data Monitoring Plan 

  • Conduct Site Training

  • Site Management

  • Monitor Subject Enrollment

  • Manage Site Communication and Trial Related Issues

  • Conduct Interim Monitoring Visits

  • Evaluate Patient Eligibility

  • Adverse Event Monitoring

  • Monitor Drug Accountability

  • Trial Closure

  • GCP Quality Process

 

Rapid Study Start-Up

  • Feasibility

  • Investigator Identification

  • Site Qualification Visits

  • Regulatory Document Collection and Review

  • Budget Negotiations

  • Contract Negotiations

 

Medical Monitoring & Safety

  • Feasibility

  • Investigator Identification

  • Site Qualification Visits

  • Regulatory Document Collection and Review

  • Budget Negotiations

  • Contract Negotiations

 

Expert Clinical Data Review

  • Review and reconciliation of complex data:
    PK, biomarkers, imaging and other lab data

  • SAE reconciliation

  • Clinical review of patient profiles

  • Narrative review

  • Review of endpoint assessment

  • Statistical output review

  • Protocol deviation review

 

Biostatistics & Programming

  • Sample size calculations

  • Randomization plans and creation of randomization codes

  • Study design and protocol development

  • Statistical analysis plans

  • Statistical analysis

  • Statistical reports

  • Statistical consulting

  • Statistical representation at FDA meetings

  • CDISC data conversion

  • Statistical programming of ADaM datasets and post-text Tables, Listings, and Figures

  • Define.xml

 

Data Management

  • EDC services provided using IBM/Merge Healthcare

  • Database build

  • eCRF development

  • Edit check programming

  • Master user list setup

  • Portal setup

  • User training

  • IRT integration

  • Clinical data management

  • EDC developers have built >35 trials

  • CDMs average >10 years industry experience

 

Medical Writing

  • Protocol development

  • Investigator Brochures

  • Informed Consents Forms

  • Clinical Study Reports

  • SAE Narratives

  • Annual Reports

  • INDs and other regulatory documents

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