Cloudaccess - Joomla! as a service

Services

 

Central and Local IRB Services

  IRBCo was founded in 1981 and has been providing central and local IRB services with excellence for the past several decades.  Features which have allowed us to build lasting relationships with our clients are as follows:
  • Full-time Medical Director on staff
  • Team leaders have Certified IRB Professional (CIP) distinction
  • Web-based full feature study submission and management system
  • 21 CFR Part 11 compliance
  • Quick document turnaround
  • Sponsors access to ALL study documents
  • Extensive Phase I – IV research experience
  • Registry Studies
  • Socio-behavioral and Educational Studies
  • Pharmaceutical and Medical Device expertise
  • Free Training for Sponsors and/or Investigators
  • Dedicated Single Point of Contact for every study
  • Translation Services
  • Budget friendly Pricing System
IRBCo has the experience and passion to provide your study teams with the highest levels of customer service and human subject protections.

 

Consultation

Consultation is available by experienced professionals in various aspects of clinical research;

  • informed consent development
  • research design
  • training development
  • GCP relating to human subjects’ protections.
This consultation is independent of board review and doesn’t guarantee board’s approval.  Please contact us with any comments or questions. We will be happy to review your project and provide a price estimate.

Management of Document Translation

Industry recognized Certified Translation Companies provide Certified Translations of your study documents. IRBCo. staff will manage the submission of IRB approved documents for translation and ensure translated documents are expedited to Sponsor/Site through eProtocol.

Training

IRB staff and consultants are available to train study staff about regulatory and other aspects of clinical research.  Training can be arranged online or in person.  Please review our training section or contact us for further information.

Data Safety Monitong Board (DSMB)

IRBCo offers experienced, efficient, and truly independent DSMB services for the broad range of clinical trials, from small Phase I projects to large, international Phase III trials and Phase IV studies. The independent DSMB members have chaired and participated in scores of clinical trial DSMBs across multiple disease specialties. Our DSMB members have expertise in specific diseases, in ethics, patient advocacy, and in biostatistics

Experienced, independent Data and Safety Monitoring Boards (DSMBs) are crucial for optimal ethical and scientific conduct of individual clinical trials and for the perceived integrity of clinical research enterprise as a whole by the public and regulatory agencies. DSMBs are an important, often under-appreciated, component of clinical trials with wide-ranging responsibilities to trial participants, investigators, trial sponsors, local human subject committees, and national regulatory agencies. To fulfill these obligations, DSMB activities must be carried-out by those with DSMB experience and with complete independence from the trial investigators and the sponsor. Yet, in most cases, the DSMB members are chosen by the trial sponsor, and organization of the DSMB is often delegated to those with little experience, almost as an afterthought to trial initiation.

Please contact us with any questions or to request pricing.