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FutureSearch Clinical Trials, L.P. EARLY PHASE CAPABILITIES 5508 Parkcrest Drive, Suite 300 Austin, TX 78731 Presented By Bobbie Theodore Alliance Director.

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Presentation on theme: "FutureSearch Clinical Trials, L.P. EARLY PHASE CAPABILITIES 5508 Parkcrest Drive, Suite 300 Austin, TX 78731 Presented By Bobbie Theodore Alliance Director."— Presentation transcript:

1 FutureSearch Clinical Trials, L.P. EARLY PHASE CAPABILITIES 5508 Parkcrest Drive, Suite 300 Austin, TX Presented By Bobbie Theodore Alliance Director

2 FutureSearch Clinical Trials, L.P. F ACILITY Brodie Ranch Rehabilitation and Healthcare Center – licensed healthcare facility built with attention to patient care, safety and convenience 4 units, 120 beds with one unit (30 beds) designated for research, with overflow beds if needed Semi-private rooms, can house caregivers 24-hr locked unit, CRU fire alarm system, synchronized timing/clock system throughout Crash cart, MDs on call 02SAT Meter Cardiac monitoring capability 24-hour medical staff Licensed kitchen with full-time chef for in-house meals

3 FutureSearch Clinical Trials, L.P. F ULL T IME S TAFF Full-time inpatient staff PI with 10+ years research experience 2 MD Sub-Is – 1 Psychiatrist & 1 Neurologist Multiple full-time doctorate-level raters RNs and LVNs ACLS/ALS or BLS certified Site manager with 10+ years research experience CCRCs with up to 10 years research experience Fulltime dedicated recruitment specialists Special pharmacy services including IV dose preparation, randomization, blinding, radio-labeling

4 FutureSearch Clinical Trials, L.P. T RIAL E XPERIENCE Phase II – IV Trial Experience Since 1998 Pediatric to adult ADHD, addictions; alcohol dependence, smoking cessation, eating disorders, anxiety, bipolar depression and disorder, depression, mild cognitive impairment, schizophrenia, schizoaffective disorder Early Phase Trial Experience Phase I MDD and schizophrenia 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 Interest/Capacity in addition to above Phase I healthy, pain, sleep, and general medical special patient populations

5 FutureSearch Clinical Trials, L.P. C APABILITIES Experience and Capabilities Psychometric ratings Extensive PKs and ECGs EEG/qEEG, evoked potentials Cardiac/telemetry monitoring QtC and TQT Ambulatory BP monitoring / holter monitoring Delivery systems: IV infusion, intra-muscular, oral, transdermal patch, device OP exam capabilities within one mile 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. Davids South Austin Medical Center

6 FutureSearch Clinical Trials, L.P. Clinical/Analytical Specimens and Laboratory Central lab Relationship with CPL local certified lab for high priority local laboratory processing 1-2 day turn-around time for safety lab report results 24/7 Pick-up Electronic transmission capabilities Refrigerated and ambient centrifuges Alarmed refrigerators/freezers (-20, -70 and -80 degrees) monitored daily by staff Back-up Generator Laboratory and data collection

7 Phase I and IIa Sample Metrics Study Title # of Patients Screened # of Patients Randomized/ # of Patients Completed Length of Enrollment YearStatus 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 weeks201 1 Closed 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 months201 1 Closed A Phase IIa Study Investigating the Potential Interaction Between XXX and Antipsychotic Treatments in Subjects with Schizophrenia or Schizoaffective Disorder 149/812 weeks201 0 Closed 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 months201 0 Closed – Top Enrollin g Site

8 Phase I and IIa Sample Metrics ( cont'd ) Study Title # of Patients Screened # of Patients Randomized/ # Completed Length of Enrollment YearStatus 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 months2008Closed 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 months2008Closed 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 month2007Closed

9 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 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 s 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

10 Retention High Retention/ Low Drop Out Experienced MD 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 meals and protocol mandated special diets if required Refreshment cart for visitors/ families Transportation provided by site when needed for compliance with scheduled visits Dedicated staff for regular contact with patient and family Lounge, break room, dining room with kitchen

11 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

12 Testimonials Dear Dr. Garcia and the [FutureSearch Trials] study team, I am quite impressed with how extremely well you have recruited, enrolled, and completed so many subjects, e.g., LESS THAN 2 months from your initiation visit. Outstanding effort and I thank and congratulate you all on a tremendous effort. YOU ALL are responsible for exceeding expectations. You are incredible. My sincere thanks, ~Phase I Depression Study Sponsor I wanted to let you know what a nice job Dr. Garcias site has done in our adult ADHD trial. He is our highest recruiter by far! Very knowledgeable and good work. He will be on our upcoming studies as you are aware. ~ADHD Study Sponsor Dr. Garcia, I was working on the data review for this month and I wanted to tell you that your data looks very clean and impressive. I can tell that you work hard to follow the eCRF Completion Guidelines and I wanted to tell you that I notice it and I appreciate it. Many of the other sites could learn about complete and accurate data entry from you. (dont tell em I said that!) Keep up the good work! ~Schizophrenia Study CRO

13 Rating Experience Includes: ADAS-COG ADCS ACDS AIMS AISRS/ADHD RS-IV ASEX BACS BAI BARS BAS BDI BPI-SF BPRS BSS CAI CANTAB CAARS CADSS CDR CDR-SOB CDSS CGI-BP/I/S/SCA-S CIBIC COG STATE CPRS CPT CRTT C-SSRS DAD DCSQ DESS DS DSM-IV Diagnosis DSST ESRS ESS FAQ FAST FIQ FMS FOSQGAF GAS GBI HAM-A HAM-D HIS HUI ISI KBIT K-SADS LSEQ MADRS MATRICS MCCB (Matrics) MGH ATRQ MINI MMSE MOS MOS-SS MSLT NAB NPI NSA NTB NYPRS PANSS PDQ PGA POMS PQAS PSP PSQI PUTS PWI QIDS-16 Q-LES-Q RAVLT RSQ – D/W RUD-Lite RUSP RUQ SANS SAS SASS SBQ-R SCID SCL-90 SCoRS SDS SQLM SRTT STS SWN TMTP 1, 2 TSSR UPDRS VAS WCST WMS WOMAC WPAI WTAR UPSA YBOCS YGTSS YMRS Certified, experienced raters, including M.D., Ph.D. and M.A.-level

14 Curriculum Vitae Click on names to view CVs: Donald J. Garcia, Jr., M.D. Donald J. Garcia, Jr., M.D. – President and PI John Douglas Hudson, M.D. John Douglas Hudson, M.D. – PI Juan Carlos Gonzalez, M.D. Juan Carlos Gonzalez, M.D. – Sub-I Stacey Stewart Stacey Stewart – Primary Rater Michael Heubner Michael Heubner – Psychometric Rater Jesse Loudin, M.Ed., CCRC Jesse Loudin, M.Ed., CCRC – Director of Clinical Research Multiple dedicated study coordinators and RAs on staff

15 Sponsor Relations Team Expedited feasibility and budget/contract negotiation handled by single point of contact with Site Relations Team. Our team is responsible for handling the business development needs of the group, sponsor and CRO relations, facilitating the site selection process (CDAs, feasibility questionnaires, CVs, site capabilities information), keeping in regular contact for feedback and garnering new study opportunities so the site personnel can focus on their studies in process. There is no charge to sponsors or CROs for these services. Jeanette Caruso Budgets/Contracts Manager Bobbie Theodore Alliance Director (866) Annie Speno Operations Manager


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