futuresearch clinical trials, l.p. 5508 parkcrest drive, suite 300, austin, tx 78731 early phase...
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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 [email protected]
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.
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
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
FutureSearch Clinical Trials, L.P.
Phase I and IIa Sample Metrics
Study Title
# of Patients
Screened
# of Patients Randomized/ # of Patients Completed
Length of Enrollme
nt YearMet
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
12 12/12 6 weeks 2011 Yes
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
9 8/7 4 months 2011 Yes
A Phase IIa Study Investigating the Potential Interaction Between XXX and Antipsychotic Treatments in Subjects with Schizophrenia or Schizoaffective Disorder
14 9/8 12 weeks 2010 Yes
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
49 24/14 5 months 2010 Yes – Top
Enrolling Site
Study Title
# of Patients Screene
d
# of Patients
Randomized/ #
Completed
Length of Enrollmen
t YearMet
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
18 18/18 2 months 2008
Yes
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
9 6/5 8 months 2008
Yes
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)
10 7/5 1 month 2007
Yes
Phase I and IIa Sample Metrics (cont’d)
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
RetentionHigh 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
ADAS-COGADCSACDSAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBPI-SFBPRSBSSCAICANTABCAARSCDRCDSSCGI-BP/I/SCIBIC
COG STATECPTC-SSRSDADDCSQDESSDSM-IV DiagnosisDSSTESRSESSFIQFMSFOSQGAFHAM-AHAM-DISIK-SADSMADRSMCCB (Matrics)MINI
MMSEMOSMOS-SSMSLT NABNPINSANTBNYPRSPANSSPGAPOMSPQASPSPPSQIPUTSPWIQIDS-16Q-LES-QRSQ
SANSSASSASSSBQ-RSCIDSCoRSSCL-90SDSSQLMSTSSWNTSSRWCSTWMSWOMACWPAIWTARUPSAYBOCSYGTSSYMRS
Rating Expertise Includes:
Certified, experienced raters, including M.D., Ph.D. and M.A.-level
Curriculum VitaeClick on names to view CVs:
Donald J. Garcia, M.D. – President and PI John Douglas Hudson, M.D. - PI Juan Carlos Gonzalez, M.D. – Sub-I Stacey Stewart – Primary Rater Michael Heubner – Psychometric Rater Jesse Louden, M.Ed., CCRC – Director of Clinical Research
Contact InfoWebsite: www.clinicaltrialcenters.com
For more information or to arrange a site visit, please contact Alliance Team:
Bobbie Theodore – Alliance [email protected] email(866) 669-0234 or (916) 939-6696
Annie Speno – Operations [email protected] email916-934-0569 phone / 866-745-8708 fax
Jeanette Caruso – Site Liaison & Budgets/Contracts Manager
[email protected] email916-933-3023 phone / 916-933-3097 fax