Principal Investigators
The Phase I Clinic
Clinical Areas
- 2 Exam Rooms
- 1 Treatment Chair
- 1 Treatment Chair for blood draw and procedures, as needed
Clinical Laboratory
- START Pediatrics has an on-site laboratory that can perform same day testing. This includes:
- Complete Blood Count (CBC)
- Renal function
- Liver function
- Hepatitis/HIV tests
- Coagulation tests
- Tumor markers
Clinical Equipment
- Crash cart complete with intubation equipment
- Infusion pumps
- Syringe pumps
- Electronic vital signs monitoring
- All equipment is annually inspected and calibrated
ECGs
- Our clinicians have experience with utilizing ELI 150 and ELI 250 equipment from central vendors.
Investigational Drug Section (IDS)
Drug Shipment Address
Attention: TBD
START Pediatrics
HM Montepríncipe – Unidad de Hematología y Oncología Pediátrica
Avda. de Montepríncipe, 25, Floor -1
28660, Madrid
Pharmacy Equipment
- All equipment is annually inspected and calibrated and includes the following:
- Biological safety cabinet
- Negative pressure clean room
- Positive pressure anteroom
- Secure medication storage room with continuous temperature monitoring for both cold storage and room temperature storage
- 1 pharmaceutical grade -20°C freezer
- 1 pharmaceutical grade -80°C freezer
- 1 pharmaceutical grade refrigerator 2 – 8°C
- Room temperature storage shelving (20 – 25°C)
Medication Preparation
- Detailed storage, handling and preparation instructions are required.
- Procedure to prepare investigational drug
- Compatible IV bags
- Compatible IV tubing for infusion pumps
Medication Screening
- Pharmacists screen and document prestudy concomitant medications using protocol eligibility criteria, Lexicomp and Crediblemeds.org to identify prohibited medications and other potential drug interactions of concern.
Drug Diaries
- Due to the potential for staff exposure to hazardous materials the IDS will not maintain any empty or partially empty container left from the preparation of investigational doses, this includes both IV and PO dosage forms.
Pharmacokinetics
PK Shipment Address
Attention: Belén Lapuente Suanzes
START Pediatrics
HM Montepríncipe – Unidad de Hematología y Oncología Pediátrica
Avda. de Montepríncipe, 25, Floor -1
28660, Madrid
Laboratory Equipment
All equipment is annually inspected and calibrated and includes the following:
- Refrigerated / room temperature centrifuges (3000g(rcf )/4400 rpm)
- -80°C / -20°C freezer with continuous temperature monitoring
- Pharmaceutical grade refrigerator 2 – 8°C
- Room temperature storage shelving
Shipping Capabilities
PK department staff are IATA shipping certified. Specimens may be shipped same day, weekly, or monthly.
Biopsy Specimens
PK department staff are present at the time of biopsy and process specimens according to protocol requirements.
Archival Specimens
- PK department staff request and process archival specimens
- Tumor blocks or unstained or slides are obtained and sent to sponsor or designee
Specialty Labs
PK department staff routinely process and ship to Central Lab specimens such as biomarkers, PBMCs, DNA, hair follicle specimens, and other specialty labs.
Regulatory Affairs & Data Management
Data Entry Capabilities
- Every study has a dedicated START Clinical Research Assistant (CRA).
- START has experience with a wide variety of electronic data capture systems (i.e., Medidata RAVE, InForm, Tempo, DataTrak, etc.).
- START ensures clean, accurate, and timely data entry and query resolution.
- 10 business days for data entry
- 5 business days for query resolution
On-site Monitoring Area
- 1 monitoring workstations with high-speed Internet and desktop computers for accessing the EMR
- Wi-Fi is available for EDC access
- Basic office supplies, copier, and telephone are available
- On-site monitoring hours are Monday – Friday, 8am – 3pm, with flexibility, provided that any adjustments are agreed upon between the coordinators and the monitors
Remote Monitoring Services
- START’s remote monitoring service allows the monitor to have access to our EMR and e-ISF (Veeva) systems without having to be on-site.
- Remote monitoring hours are Monday – Friday, 8am – 3pm, with flexibility, provided that any adjustments are agreed upon between the coordinators and the monitors.
Scheduling Monitoring Visits
- The assigned START CRA is the main point of contact for the scheduling of all on-site and/or remote monitoring visits (i.e., initial, interim, and close-out visits, etc.).
- Monitor visits must be scheduled at least 30 days in advance.
- Requests for co-monitors must be reviewed by the study team and approved by the Principal Investigator.
Hybrid Monitoring (Onsite and Remote)
- Monitors will be required to conduct on-site and remote visits during the following times:
- First monitoring visit and once per quarter may be conducted ON-SITE
- All other visits will be conducted REMOTELY
