Business operation description
The daily business operation of NWCT is as follows. A study lead is identified by the company from several sources. First, we have many contacts with the Pharma and Contract Research Organizations (CRO’s) stemming from 10 years of research experience. Second, we pay a monthly fee to an organization which supplies us with four to six new leads per week. Thirdly, we are in constant contact with clinical trial monitors visiting our sites and updating our company with prospective new trials. A questionnaire is completed by our staff outlining our capabilities and previous experience in the particular field of interest. At this point the sponsor or CRO will request a site selection visit, if necessary, and then the site selection process is finalized. Once our sites are selected we start budget negotiations. No contracts are signed without the approval of the CEO and COO.
Once contract and payment terms have been established an investigator meeting is attended by the study coordinator and principal investigator to review protocol specifics. Each site receives a minimum number of research subjects that need to be completed per contract. Typically our sites over enroll studies which makes us an attractive group to work with since enrollment timelines are typically extended due to slow enrollment across all sites nationally and internationally. Once study enrollment begins, advertising, funded by the sponsor/CRO, ensures proper enrollment targets are attained. Occasionally, when warranted, site funds are allocated to advertising to ensure these targets are met. This general scenario pertains to late phase studies which do not require overnight confinement. Early phase trials typically do not involve an investigator meeting as the site works more closely with the sponsor/CRO planning execution of the trial. We have a dedicated advertising/recruiting staff at each site with proven expertise enrolling a wide range of clinical trials.
Early phase clinical trials typically require one to several days of confinement in the research facility. Utilization of flex scheduling of contracted staff allows seamless coverage without the overhead burden of full time employees. This staffing model allows for several studies to be performed at any of our sites thus maintaining continuous revenue stream.
Certified study coordinators and physicians conduct each trial with direct oversight by the principal investigator ensuring compliance with all federal regulations, ICH/GCP guidelines. This maintains the highest level of evaluable data which places our company in preferred status for upcoming trials and gives us a competitive edge for negotiating more favorable budgets.
Training is obtained through purchased educational materials which are regularly updated to maintain accuracy in the industry. All members of the study staff receive continuing education credits through ACRP/APPI sponsored events and online programs.
Certification of all eligible staff members is mandatory at NWCT. The company covers costs of examinations and review materials as a policy to show our commitment to excellence in every aspect of clinical trial conduct.
Our standard operating procedures encompass all aspects of management and employee conduct. These policies are reviewed annually by all employees and are continually reviewed and revised to keep pace with the ever changing research landscape. Quality control is an internal fuNWCTion involving constant peer review and discussion. Open dialogue between management and staff enables processes and work flow adjustments to be made in real time, thus optimizing our opportunity to increase our competitive edge in the marketplace.
In summary, the goal and focus of NWCT as a dedicated research company is to supply clean data in a timely fashion while maintaining subject safety benefiting both the communities we serve and the drug development industry.