Medsol Clinical Research Center

Under Construction

About Us
Mission
Staff
Facility
Contact Us
Location

Medsol Clinical Research Center is a clinical research organization specializing in clinical studies in Pediatric and Adult Populations.

Our staff is compromised of Primary Investigators, several Sub Investigators and nurses/research coordinators. We hold a Partnership with Endocrinology, Cardiology, Internal Medicine, Allergy/Immunology and Neurology Physicians with access to their databases. Collectively, our staff has over 25 years of Research Experience.

Our Investigators, Sub Investigators and Research Coordinators have undergone extensive training in Good Clinical Practice (GCP) and in Medsol specific Standard of Operating Procedures (SOPs). Our Coordinators are IATTA certified and have experience in Electronic CRF's.

Medsol utilizes a central IRB, which allows for an efficient/expedited research approval process. We excel in recruitment abilities, low query rate, quick regulatory and contract turn around.

We pride ourselves in being leaders in Advanced Pediatric and Adult Clinical Research and above all the superior quality of care that our patients receive.

Under Construction

Staff

Under Construction

Site Facility and Capabilities Summary

Medsol Clinical Research Center is a freestanding, purpose built, 1400-sq.ft medical research facility
completed in November 2009. It is centrally located in the “Promenades Plaza” approximately .25 miles from
the two hospitals in town and the main city bus line services the facility. Our parking lot accommodates more
than 100 vehicles and there is designated handicap parking directly at our entrance to include a
handicap entrance ramp.

Location and Amenities

Our location was specifically chosen for the comfort and convenience of study participants. It is our intent to
avoid the institutional and at times stressful environment of Medical office Parks. We are in a cheerful, safe
and pleasant mixed retail-residential neighboorhood with shopping, coffee shops and food facilities nearby. Our
facility is professionally decorated to provide the subjects and visitors with a “comfortable home like” ambiance.

Emergency Resources

Fawcett and Peace River hospitals are within .25 miles of the facility. They are both teaching hospitals and
the Investigators working with Medsol are affiliated with the institutions and hold admitting priviledges.
In case of an emergency, the SOP at Medsol is to call 911. The EMT station is less than 2 minutes away.

Code Compliance

The bulding and its facilities have full handicap access with patient, laboratory and administrative areas
situated on the ground floor. The facility meets or exceeds all apllicable building codes and is compliant
with the higher standards required or recommened for medical facilities, including ; emergency lighting,
handicap compliant emergency exit, and laboratory grade flooring. The site is centrally monitored for fire
and intrusion on a 24 hour basis through a central alarm service (ADT). This includes electronic keypad door
locks to enter from the waiting area and to access the drug room storage/library room.

Investigational Drug Storage, Monitoring and Security

The 100+ square foot investigational drug storage room is situated in the rear of the office. In addition,
it has an electronic keypad door lock and it is rescticted to staff only access. There are two refrigerators
that are temperature monitored M-F (no weekends no holidays) and the temperature is recorded on a site specific
log. There are 2 separate wall mounted cabinets within the secure storage room. The storage cabinets are
temperature monitored with recording on a site specific temperature log

(Monday thru Friday no weekend or holidays). In addition, the room temperature is monitored via ADT on a
24 hour 7 day a week basis. A high or low out of norm range will trigger a phone alert via a wireless
connection to the Director of Research.

Information Technology

The site is equipped with high speed, broadband internet service, “Cat 6” cabling, a secure
firewall and networked Apple Computers and PCs. Files are automatically backed up. Wired or 256-bit
secured wireless access is available to Study Monitors, Sponsors and visitors. IT specialist is
available to address technical needs 24 hrs a day.

Monitor Facilities

Study monitors and other Sponsor Visitors are provided with private offices with phones and internet access.
Self Serve refreshment are provided and parking is at our front door.

Our Research Facility Also Includes:

    • Partnership with Endrocrinology, Internal Medicine and Neurology Physicians with access to their database.
    • Staff: 2 full time coordinators with IATTA training
    • Two Handicap accessible restrooms.
    • Two dedicated Exam rooms and a lab phlebotomy area.
    • A dedicated copy/fax/scan machine with designated phone line
    • Paper based medical records
    • Dedicated room for monitoring visits with hard wired and wireless internet access.
    • 6 computers with DSL internet connection and email access (4 Macs and 2 PC which all access printer       wirelessly).
    • A kitchen area to staff and visitors which permits us to offer beverages to waiting study
      subjects and breakfast to those subjects that have fasting blood sampling (according to their protocol).
    • Local laboratory affiliation with Sunrise Lab, Port Charlotte Florida. Routine and emergency
      collections are available 7 days a week. Lab certificates and lab norms are available upon request.

Lab:

    • 1 locked refrigerator with temperature log.
    • A -25?C locked freezer with temperature log.
    • Ambient centrifuge (calibrated yearly).
    • OSHA compliant: spill kits and eye wash station, and sharp containers.
    • CLIA waiver certificate.

IP:

    • 2 wall secured lockable cabinets for drug storage, monitored M-F
    • 2 Locked IP refrigerators

Equipment:

    • Manual and electronic blood pressure devices (calibrated yearly)
    • ECG= Midmark Diagnostic Group. (certificate
    • Electronic scale (up to 400 pounds and calibrated yearly)
    • Stadiometer.

Emergency:

    • Emergency Kit with oxygen tank, ambubag and access to 911.

Main Telephone: 941.623.9744

Fax: 941.623.9743

3280 Tamiami Trl, Port Charlotte, FL

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