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FutureSearch Clinical Trials, L.P. 5508 Parkcrest Drive, Suite 300, Austin, TX 78731 EARLY PHASE CAPABILITIES. Presented By Bobbie Theodore, Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com. FutureSearch Clinical Trials, L.P. Facility
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FutureSearch Clinical Trials, L.P. 5508 Parkcrest Drive, Suite 300, Austin, TX 78731 EARLY PHASE CAPABILITIES Presented By Bobbie Theodore, Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com
FutureSearch Clinical Trials, L.P. • Facility • Affiliated with Texas Neuro Rehab Psychiatric Residential Center • 14 rooms (28 beds) • 24-hr Locked Unit, CRU fire alarm system, synchronized timing/clock system throughout • Cardiac Monitoring Capability • 24-hr Medical Staff • Licensed Kitchen with full-time chef for in-house meals • Full Time Staff • Full-time Inpatient staff • PI with 9+ years research experience • 2 MD Sub-Is – 1 Psychiatrist & 1 Neurologist • Full-time MD and PhD-level raters • RNs, and LVNs ACLS/ALS or BLS certified • Site Manager with 8+ years research experience • CCRCs with 5+ years research experience • Recruitment specialists with over 6 years research experience • Provides special pharmacy services including IV dose preparation, randomization, blinding, radio-labeling
FutureSearch Clinical Trials, L.P. • CNS Trial Experience Since 1998 • Pediatric to Adult ADHD, Addiction, Alcohol Dependence, Anxiety, Bipolar Depression and Disorder, Depression, Eating Disorders, Mild Cognitive Impairment, Schizophrenia, Schizoaffective • Early Phase Trial Experience • Phase I MDD • Phase I bio-equivalence bipolar, and acute agitation associated with bipolar disorder • Phase IIa Schizophrenia, and Schizoaffective Disorder • First human dose/first in man with new chemical conducted within last 2 years • ADHD
FutureSearch Clinical Trials, L.P. • Experience and Capabilities • Psychometric Ratings • Extensive PKs • 3T MRI Scanner capable of FMRI Procedures • EEG/qEEG, Evoked Potentials • Cardiac/Telemetry Monitoring • QtC and TQT • Ambulatory BP Monitoring • Holter Monitoring • OP Exam capabilities within one mile • Infusions • Emergency Capabilities and Training • Staff trained and qualified in use of emergency crash cart, CPR, AED, oxygen tank • Stocked emergency cart checked every shift • Automatic defibrillators on site tested and calibrated annually • 5 miles to nearest trauma or intensive care center – Fully Accredited St. David’s South Austin Medical Center
FutureSearch Clinical Trials, L.P. • Clinical/Analytical Specimens and Laboratory • Relationship with CPL local certified lab for local laboratory services • 1-2 day turn-around time for safety lab report results • 24/7 Pick-up • CPL for high priority processing • Electronic transmission capabilities • Refrigerated and ambient centrifuges • Alarmed refrigerators/freezers (-20, -70 and -80 degrees) monitored daily by staff • Back-up Generator • Data Collection • Collection and integration of laboratory data, images and scans • Call center with detailed metrics and recruitment plans tailored to each study • Central or local lab
Recruitment • Austin, TX - Over 1 million population • Site Database of 10,000+ subjects across all indications accumulated over 10 years of research • Full-time field-based recruiters with direct access to and contact with patients through board and care homes and community groups for referrals including from The Lakes, a local inpatient psychiatric unit • Community Outreach efforts include attending community events, providing free seminars, lunch and learns, and distributing flyers • Full-time Community Liaison builds and maintains relationships with a network of local physicians (Neurologists, Psychiatrists and Internists) with access to patient databases for additional patient referrals • Internal Call Center with 4 full-time staff members field calls and emails from interested participants and schedule them accordingly with our clinicians to be further evaluated • Full-time Marketing Manager • Ability to pre-qualify patients via IRB-approved pre-screen consent form for queries allowing non-evasive procedures • Relationship with media buyer with history of successful advertising
Retention • High Retention / Low Drop Out: • Experienced M.D. always available on site at all patient visits • Highly trained and experienced staff very knowledgeable and comfortable working with these patient populations • Flat screen TVs in some rooms and in all common areas • Wireless Internet and community computers allows patients to keep in touch • Caterer prepares palatable meals and protocol mandated special diets if required • Transportation provided by site when needed for compliance with scheduled visits • Dedicated staff for regular contact with patient and family to promote retention • Lounge, break room, dining room with kitchen
Site Advantages • Swift start up – Central IRB • IRB-approved pre-screen consents to pre-qualify subjects • PI provides clinical feedback and protocol consult during development process if needed • Ability to recruit quality patients • Low drop out / high retention • Placebo separation results • Experienced, dedicated staff and PI expertise • Favorable Sponsor and CRO audit results • Responsiveness and ease of single point of contact with Site Relations Team: Bobbie Theodore, Annie Speno and Jeanette Caruso
Rating Expertise Includes: Certified, experienced raters, including M.D., Ph.D. and M.A.-level
Contact Info • Website: www.clinicaltrialcenters.com • For more information or to arrange a site visit, please contact Alliance Team: Bobbie Theodore – Alliance Director clinicaltrials@btheodore.com email (866) 669-0234 or (916) 939-6696 Annie Speno – Operations Manager annie@btheodore.com email 916-934-0569 phone / 866-745-8708 fax Jeanette Caruso – Site Liaison & Budgets/Contracts Manager jeanette@btheodore.com email 916-933-3023 phone / 916-933-3097 fax