The Drug Study Institute is located at The Jupiter Preventive Internal Medicine Center, a division of The Jupiter Preventive Medicine Center, formerly called The Jupiter Research Institute.
 The Drug Study Institute is looking forward to working with you on your next Investigational New Drug (IND) trial. The Jupiter Preventive Internal Medicine Center is a primary care practice conveniently located on the campus of The Jupiter Medical Center.
 Both Dr. Saponaro and Dr. Sanger have been involved with all phases of clinical research since 1997. We employ three full time dedicated study coordinators to assist in all study related activity. We respond to your phone calls and faxes in a timely fashion. We enjoy the ability to use a central Institutional Review Board (IRB). We have both passed the certifying exam given by the Association of Clinical Research Professionals (ACRP) codifying formal recognition as certified clinical research coordinators (CCRC) and certified clinical research investigators (CCRI), the Clincial Research Certification Examination by the Society of Clinical Research Associates (SoCRA) which entitles us to use the title CCRP after our names in recognition that we are Certified Clinical Research Professionals. We are also board certified by: the American Academy of Pharmaceutical Physicians (AAPP), CPI; Drug Information Association (DIA), CCI. We are members of the following organizations: The American Association of Pharmaceutical Scientists (AAPS); The American Pharmaceutical Association (APhA); and The American Association for Clinical Chemistry (AACC). We are also actively forming a local chapter of the ACRP here in Palm Beach County. Analysis of our center's metrics reveals we routinely enroll a large number of patients quickly. We take great care and pride in filling out clean and precise case report forms (CRFs) and in communicating with your clinical research associate (CRA) and with the sponsor in a timely fashion.
 Our project manager's responsibilities include:

1. Central Computer File Management with Study Manager
2. Collection and Review of Regulatory Documents
3. Tracking Study Progress
4. Maintaining Study Supply Kits
5. Preparation of CRO/Sponsor Communications
6. Ensuring that the rights and well-being of human subjects are protected
7. Ensure trial data is accurate, complete and verifiable
8. Ensure the conducts of our trials are in compliance with current approved protocol/amendment(s), with GCP and with the applicable regulatory requirements
9. Ensure CRFs are completed and up to date
10. Ensure clinic medical chart from The Jupiter Preventive Internal Medicine Center, source documents and shadow charts from our Drug Study Institute are completed and up to date for all research volunteers
11. Ensure Regulatory Binder is kept well organized, complete and that all items are current
12. Ensure our visiting CRAs have dedicated comfortable monitoring space equipped with DSL computer, phone, copy machine, fax and any food or comfort items they may require to improve their experience with us
13. Coordinate visits with the monitoring CRAs and the DSI study staff
14. Update study progress at our site and investigate ways of improving enrollment and data quality
15. Review any protocol deviations/violations; ensure that DSI staff communicates them to the sponsor's CRAs and that the appropriate waiver forms are obtained and documented properly
16. Help recruit new staff as needed
17. Help maintain record of CRC training
18. Review study medication issues
19. Review study timelines and expectations; propose plans of action to improve performance
20. Provide excellent service in a sprit of teamwork and collaboration along with a commitment to working together to ensure quality and compliance
21. Provide follow-up on all outstanding action items in a timely fashion
22. Maintain a delegation of site personnel responsibilities record for all DSI personnel who will perform any study related tasks along with updating them as necessary to ensure completeness during a trial

 We are available to attend your investigator meetings. When CRAs visit us, we maintain a private office for them to work in that includes a private phone line and a computer.
 Please consider The Drug Study Institute for your next IND Trial.