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Clinical Operation

About service

To collaborate with clients to meet the increasing complex clinical trial environments and harsher regulations of regulatory authorities and offer its innovative oncology drug development solution, C&R Research organized an oncology drug development services team in 2009, employing professionals with vast experience across a broad range of therapeutic areas. Their expertise and innovative approaches have enabled C&R Research to provide comprehensive oncology development services in all phases of clinical trials.

Drug Development Program Management Services

Adaptive Trial Design

Phase I/Phase IIa/Phase IIb/Phase III/Phase IV/EAP

Project Management

  • Project Strategic Planning
  • Feasibility
  • Investigator/Site Identification & Qualification
  • Pre-Study Visit
  • Investigator Meeting
  • IRB Affairs
  • Initiation Activities
  • Site Personal Training
  • Site Monitoring Activities
  • Close-Out Activities
  • Site Management
  • Project Management
  • Vendor Communication
  • IP Management
  • SAE Management
  • Document Management
  • Audit / Inspection Supporting

Central Monitoring Clinical Trails (Data Review)

  • Critical Data Quality
  • Protocol Compliance
  • Site Data Quality Matrix
  • Other Data Related Issues

Clinical Data Management Analysis and Reporting

Drug Life Cycle Management

Vast experience and expertise across a broad range of therapeutic areas

To this date, C&R Research’s oncology drug development services team has conducted more than 100 oncology clinical trials of 25,000 patients at 1,000 sites, with extensive experience in 25 therapeutic areas in oncology. In particular, C&R Research’s experts are well-versed in hematology, oncology, solid tumors, and cell/gene therapies and helps clients conduct successful clinical trials.

Global-level oncology services in clinical trial

C&R Research’s oncology drug development services team has actively assisted new drug development process across a broad range of oncology areas in all phases of clinical trials, ranging from Phase I to post-approval and expanded access program (EAP). Using the global standard formats, such as CDISC (Global Data Standards), SDTM (CDISC-Data Tabulation), ADaM (CDISC-Data Analysis), and E2B (ICH Clinical Safety Data Management Guide), C&R Research is engaged in the pivotal and supportive clinical trials process that may lead to final approval of global drug regulatory agencies.

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