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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
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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.
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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
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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.
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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 FutureSearch Clinical Trials, L.P.
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Phase I and IIa Sample Metrics Study Title # of Patients Screened # of Patients Randomized/ # of Patients Completed Length of EnrollmentYear Met Target? A Phase I Effect of XXX on Ambulatory Heart Rate and Blood Pressure in patients with Major Depressive Disorder who are being Treated with Selective Serotonin Reuptake Inhibitors 1212/126 weeks2011Yes A Phase IIa, Multi-center, Double-Blind, Randomized, Parallel Group, 4-Week Inpatient Treatment Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Two Fixed Doses of XXX Compared to Placebo, Using XXX as an Active Control, in the Treatment of Acute Exacerbation of Schizophrenia 98/74 months2011Yes A Phase IIa Study Investigating the Potential Interaction Between XXX and Antipsychotic Treatments in Subjects with Schizophrenia or Schizoaffective Disorder 149/812 weeks2010Yes A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety and Pharmacokinetics of two Oral XXX a Dose Regimens and Placebo during 2 weeks of Treatment in Adult Users of Nicotine Containing Products and three Oral XXX Dose Regimes and Placebo during 2 weeks of Treatment in Adult Non- Users of Nicotine Containing Products in Patients with Attention-Deficit/Hyperactivity Disorder 4924/145 months2010Yes – Top Enrolling Site
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Study Title # of Patients Screened # of Patients Randomized/ # Completed Length of EnrollmentYear Met Target? A Phase IIa Multi-center, Randomized Double-Blind, Double-dummy, and Placebo- and Active Controlled Study to Investigate the Safety and Efficacy of XXX Administered to Subjects with Major Depressive Disorder 1818/182 months2008Yes A Phase IIa, Multi-center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of XXX as Adjunctive Treatment in Combination with a Preexisting Antipsychotic in Patients with Cognitive Impairment Associated Schizophrenia in Non-Smoking Schizophrenia population 96/58 months2008Yes A Phase IIa Placebo- and Positive-Controlled, Randomized Study, Evaluating QT and QTc Intervals following administration of Immediate-release of an Atypical Antipsychotic in Subjects with Schizophrenia or Schizoaffective Disorder (involved TQT measurements and a comparator drug) 107/51 month2007Yes Phase I and IIa Sample Metrics (cont’d)
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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
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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
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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
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ADAS-COG ADCS ACDS AIMS AISRS/ADHD RS-IV ASEX BACS BAI BARS BAS BDI BPI-SF BPRS BSS CAI CANTAB CAARS CDR CDSS CGI-BP/I/S CIBIC COG STATE CPT C-SSRS DAD DCSQ DESS DSM-IV Diagnosis DSST ESRS ESS FIQ FMS FOSQ GAF HAM-A HAM-D ISI K-SADS MADRS MCCB (Matrics) MINI MMSE MOS MOS-SS MSLT NAB NPI NSA NTB NYPRS PANSS PGA POMS PQAS PSP PSQI PUTS PWI QIDS-16 Q-LES-Q RSQ SANS SAS SASS SBQ-R SCID SCoRS SCL-90 SDS SQLM STS SWN TSSR WCST WMS WOMAC WPAI WTAR UPSA YBOCS YGTSS YMRS Rating Expertise Includes: Certified, experienced raters, including M.D., Ph.D. and M.A.-level
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Curriculum Vitae Click on names to view CVs: Donald J. Garcia, M.D. – President and PIDonald J. Garcia, M.D. John Douglas Hudson, M.D. - PIJohn Douglas Hudson, M.D. Juan Carlos Gonzalez, M.D. – Sub-IJuan Carlos Gonzalez, M.D. Stacey Stewart – Primary RaterStacey Stewart Michael Heubner – Psychometric Rater Michael Heubner Jesse Louden, M.Ed., CCRC – Director of Clinical ResearchJesse Louden, M.Ed., CCRC
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Contact Info Website: www.clinicaltrialcenters.comwww.clinicaltrialcenters.com For more information or to arrange a site visit, please contact Alliance Team: Bobbie Theodore – Alliance Director clinicaltrials@btheodore.comclinicaltrials@btheodore.com email (866) 669-0234 or (916) 939-6696 Annie Speno – Operations Manager annie@btheodore.comannie@btheodore.com email 916-934-0569 phone / 866-745-8708 fax Jeanette Caruso – Site Liaison & Budgets/Contracts Manager jeanette@btheodore.comjeanette@btheodore.com email 916-933-3023 phone / 916-933-3097 fax
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