Clinical Research
Why Participate in a Clinical Study?
- Clinical trials make the practice of medicine more interesting. Physicians can take a fresh look at routine procedures and prescribing habits.
- Clinical research can enhance the physician’s reputation and/or ranking.
- Help to bring a potentially "breakthrough" product to the market that may affect thousands of lives.
- Opportunity to enroll or refer a patient, who has run out of treatment options, into a trial, which may improve his or her life.
- As reimbursements for services go down from insurance companies, participation in clinical studies can add additional revenue sources to physicians and clinics.
Purpose of Clinical Research Department
Physicians doing studies through the research department will have the benefit of a trained research staff. Physicians who undertake a clinical study without the benefit of a research staff are left on their own to balance the resources needed for maintaining their own medical practice and the time consuming responsibilities required by the study protocols. In the end, a poorly negotiated budget or mishandled documents may result in frustration and potential financial loss.
Services Provided
Once the physician has decided to participate in a study the research department would be responsible to provide the services listed below, consulting with the physician when needed.
Full Service Model
- Liaison between study sponsor, FDA and IRB and physician(s)
- Review study protocols with Primary Investigator and staff
- Prepare 1572 form, CVs and resumes of those involved in the function of the clinical trials
- Preparation of documents: Informed consent; IRB documents; study correspondence; tracking logs; signature logs, delegation of authority forms, adverse event forms, case report forms
- Cost determination for required visits, labs, diagnostic tests
- Review protocol for study profitability
- Contract negotiation, payment schedules and budget or protocol amendmentswhen needed
- Preparation for initiation visit, site visits, pharmaceutical and/or FDA audits, monitor visits and close-out visits
- Prepare study packet for enrolled subjects: Orders, lab requisitions, study visits with Primary investigator
- In-service participating staff to study protocols, supplies, adverse events
- Preparing the research chart
- Screen patients for possible study participation: past medical history, past treatment history, baseline assessment and labs, and base line signs and symptoms
- Screening visits
- Handling payment to study participants
- Document storage/disposal
- Tracking data
- Follow-up on any missing or unknown data, data corrections
- Tracking and notification for all adverse events
- Facilitate the reporting of serious adverse events to appropriate local committees and Federal agencies
- Pulling and preparing the data for queries, audits or protocol violations
- Drug storage and when necessary drug disposal
- Generation of randomization codes for subjects
- Pharmacokinetic sampling and shipping PK samples
- Write integrated clinical study report
- End of study follow-up
- Submit study documentation
Physicians wanting to be more involved in research, and want to be more hands on, may choose to contract for certain tasks to be done by the research staff while he or she is responsible for performing the remaining tasks.
Advantages of Clinical Research Department
- Proactive in obtaining study protocols
- Study Manager Software used to closely manage study operations and financials
- Full HIPAA compliance
- Certified Clinical Research Coordinator with ACLS certification
- Clinic resources that are appealing to sponsors
- Contract negotiations and budget management.