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Our Sponsors Get Quality Results Quickly

Recruitment Matters

Diablo Clinical Research has a track record of meeting or exceeding recruitment goals and consistently ranks in the top five highest enrolling sites in multi-center trials over the last five years. Our strategic location and broad-based recruitment sources ensure we fill studies quickly and meet our sponsor requirements.

Our recruitment scope of the entire bay area, plus outlying regions, includes 5.4 million people in a 6-county region. We have also built a large, detailed and diverse study patient database. Our media expertise and relationships means your clinical research project will be a success.

Recruitment Highlights:

• 3 full-time recruitment specialists
• Patients pre-identified to ensure FPFV goal met
• Consistently meet/exceed # patients enrolled & enrollment timelines
• Average study retention rate of 98%
• Ethnically diverse database with 16,000+ subjects
• Wide range of recruitment avenues
  • Social Media/ Digital Advertising
  • Radio
  • Television
  • Direct Mail

Other Recruitment Services Include:

• Community Outreach
• On-site Seminars
• Health Fairs
• Volunteer Literature
• Networking within local healthcare community

Collaboration Matters

Diablo Clinical Research is an independent research site. Our dedicated research site has conducted over 900 studies involving potential new medications and devices for a variety of health conditions.

We provide top quality care for our patients and reliable data to our pharmaceutical sponsors.

Each research study we conduct is performed in accordance with the International Conference on Harmonization of Good Clinical Practice (ICH-GCP) and the Food & Drug Administration (FDA) standards.

Investigator Oversight:

• Minimum of 2 on site at anytime
• Investigator participation in SQV, IM and SIV
• Train the coordinator on the indication/study
• Review ICF and randomization criteria real time
• Functions as the coordinator as necessary
• Interactive relationship with Sponsor/Medical Monitor for each study

Regulatory Compliance:

• Accurate and complete document submission/reporting to Sponsor/IRB
  • Deviations
  • Unanticipated events
  • SAE reporting
  • Staff qualifications
  • Study delegation
  • Training
• ICF version control
• Archive/retention of essential documents

Document Management/Archiving:

• TMF per study
  • Source document version control
  • ICF document version control
• Onsite locked storage
• Offsite long-term storage at Cor-O-Data
  • 24 hour document retrieval
• Shred-It for confidential document disposal
• Computer backup in the cloud

Quality Matters

Our data is accurate: in the last 5 years we have had 5 FDA audits and 15 sponsor audits with no findings.

When searching for a research partner, quality is key. We ensure this by offering real-time review of first subject enrolled, 4 full-time QA/QC staff, annual and bi-annual trainings for ICH/GCP, SOP’s, ICF, and AE reporting. We also provide ICF version control, accurate and complete document submission/reporting to IRB, CRO and Sponsor and we handle the archiving/retention of essential documents.

Annual and Bi-Annual Trainings:

• Documented in employee files
• SOPs
• ICH/GCP
• ICF, AE Reporting
• Continuous training on Protocol, ICF and Amendments

QA/QC:

• FT and project-based QA/QC staff
• 20% review per SOP; escalate as needed
• Real-time review of 1st subject enrolled
• Review of Sponsor DCFs
• Works collaboratively with CRAs

Lab & Pharmacy:

Lab:
• Specimens packed/shipped/stored per lab manual/protocol
• Dry ice delievered 2x per week
• Samples are shipped via courier designated by protocol
• Central or local labs or both
• Locked and monitored refrigerators/freezers for storage
• All temperature logs are archived on site

Pharmacy:
• Pharmacist on staff
  • Study coordinator unless separate pharmacist required
  • Unblinded staff include: Pharmacist or RN or MD as required
• Access and Accountability
  • Limited access via pharmacy access register
  • Full accountablity records maintained
• Mixing
  • Laminar FlowHood for sterile mixing

Facility Matters

Outpatient Unit (Phase 2-3)

12,000 square feet
• 3 exam rooms & 6 intake rooms
• Lab/ draw area/ specimen collection
• Dedicated/separate workspace for monitors with copier and T1 wired and wireless access
• Large conference room
• Offices for coordinators and MDs
• Temperature controlled, keypad locked drug/device room with locked cabinets inside
• Safe, dedicated parking lot
• Alarm secured when not in use

Inpatient Unit (Phase 1, PK/PD, Extended Stay/Overnight):

2,300 square feet
• 6 beds, 4 infusion chairs, 2 bathrooms (1 with shower)
• ACLS certified nurses and physicians
• One common ward area
• Lounge/kitchen area
• Long, open hallways
• Safe, dedicated parking lot
• Alarm secured when not in use
• Fire alarm alerts directly to fire department for 1st response
• Dedicated/separate workspace for monitors with copier and T1 wired and wireless internet
• Games, magazines, puzzles, TV for patient entertainment