Custom Protocols

Cureline Clinical and Tissue Procurement teams work closely with our customers, consulting pathologists and medical experts to create detailed custom study designs achieving research objectives in the most efficient and cost-effective manner. We address ethical, medical, and technical conciderations including patient enrollment criteria selection, sample format and preparation recommendations, data collection methodology and database entry methods. In addition, our protocol development experts will ensure that your study will be scientifically rigorous and meet the IRB (Ethical Committee) requirements in the applicable jurisdictions.

In the past Cureline designed and successfully completed a variety of studies for:

Drug research and discovery

Biomarker discovery and development

Molecular diagnostics

Companion diagnostics

Medical device testing

Study Design: Communication is Crucial for Success

Feasibility

Study Objectives:

- Purpose and scope
- Regulatory and legal (regulations and guidelines)
- Ethical standards, IRB/EC, ICF

Project Specifications:

- Patient/donor population: inclusion/exclusion criteria
- Samples collection, preparation, labeling
- Laboratory processing (protocols)
- Samples storage, shipment

Clinical Data:

- Standard (medical history, physical examination, lab data)
- Project-specific CRF components
- Database use

Logistics , deliverables and timelines

Budget and payment schedule