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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 clinicaltrials@btheodore.com www.clinicaltrialcenters.com. FutureSearch Clinical Trials, L.P. Facility.
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FutureSearch Clinical Trials, L.P.EARLY PHASE CAPABILITIES5508 Parkcrest Drive, Suite 300Austin, TX 78731 Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com
FutureSearch Clinical Trials, L.P.Facility • 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
FutureSearch Clinical Trials, L.P.Full Time Staff • 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
FutureSearch Clinical Trials, L.P.Trial Experience • 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
FutureSearch Clinical Trials, L.P.Capabilities • 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. David’s South Austin Medical Center
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
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 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 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 preparesmeals 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
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
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. Garcia’s 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. (don’t tell ‘em I said that!) Keep up the good work! ~Schizophrenia Study CRO
Rating Experience Includes: Certified, experienced raters, including M.D., Ph.D. and M.A.-level
Curriculum Vitae Multiple dedicated study coordinators and RAs on staff
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 clinicaltrials@btheodore.com (866) 669-0234 Annie Speno Operations Manager