Our clinical research practice has been operating since 2005. We have conducted over 250 clinical trials and enrolled over 2000 patients. We base our patients’ enrollment on our direct community resources. Through ongoing patient education, we are proud to maintain 99% patient retention.
We truly believe and subscribe to the theory of safety in all regards during the research process and assess benefit/risk ratio in every clinical trial.
Most frequent research indications:
- Atopic dermatitis
- Actinic keratosis
- Hidradenitis suppurativa
We are proud to offer a “speedy start-up” to all sponsors, completing required regulatory documents and contracts within 48 hours.
The practice has 17 examination rooms, out of which four are exclusive to surgeries and four others exclusive to clinical research. Our visiting parties are offered two monitor units, with access to Wi-Fi, fax machines, scanners, and copiers. Because we operate 6 days a week, we offer highly accommodating flexibility in scheduling all monitor visits with minimal advance notice.
The following is the standard equipment used by our research staff:
- 2 ECG machines (our doctors provide real-time analysis)
- X-ray facility access: BrightLight Imaging (7 min drive)
- Research room with double lock security for investigational drugs
- Temperature min/max monitored daily
- Generator (supportive of all research functions)
- -20 C freezer
- Blood pressure/temperature/oxygen monitors
- Archive room (on-site record storage)
- Scales for patient weight as well as investigational drugs
All our equipment is certified for calibration annually, and our records of maintenance are centralized and historically provided back to 2007. We operate from one location only and have full control of all our research and clinic functions (including the building, utilities, parking).
Our research staff has extensive experience and is professionally trained in Good Clinical Practice. The continuing education and training include the following platforms: eCOA, InForm, Rave, Veeva Vault, Trail Master, InvestigatorSpace, YPrime, eClinical, AdvancedMD, EMA.
Among many sponsors and vendors, the following have conducted multiple studies with us
- Eli Lilly
- Therapeutic Inc.
Our site has been inspected by FDA and PMDA (Japan) 7 times during the drug pre-approval audit and we have never received any notice of deviation or violation (no 483).