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Prosoft Clinical Services and Capabilities
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Prosoft ClinicalServices and Capabilities
2012
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Prosoft Clinical Experience
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Select List of Clients
Product Experience
Adoxa® Tablets Klaron® Lotion, 10% Retin-A MICRO® microsphere, 0.1% and 0.04% Pump
Atopiclair® Nonsteroidal Cream Lovenox® Sculptra®
Azmacort® Inhalation Aerosol Nasacort® Sculptra® Aesthetic
BenzaClin®Topical Gel Noritate® Cream, 1% Solaraze® Gel
Benzamycin®Pak Penlac® Nail Lacquer Topical Solution, 8% Taxotere®
Bystolic® Propecia® Tablets, 1 mg Zyclara® Cream 2.5%, 3.75% (Packet and Pump)
Carac® Cream PSORCON® E Emollient Ointment 0.05%
Evolence® Rilutek®
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Service Capabilities
CMC • Formulation Development• Analytical methods development• Process development and improvement• Packaging development• Manufacturing scale-up and validation• CMC reports and sections for Regulatory applications (IND, NDA, ANDA, NDS)
Biostatistics • Adaptive Design• Study Design• Study Support• Sample size determination• Randomization (e-Web Randomization Services)• Statistical Analysis Plan• Statistical analysis with report ready tables• Data Safety Committees• FDA representation/assistance
Data Management
• Electronic Data Capture System (Web-based 21 CFR part 11 compliant)• Case Report Form Design (Electronic or paper)• Database Design and Validation• Data Entry• Adverse Event and Medication Coding• CDISC Conversion of SAS Data
eTechnologies • eDC – web-enabled electronic data capture platform• eWRS – web and phone enabled interactive voice response platform for randomization, trial and drug supply
management• eXclinical – interactive data review and analysis platform• Adverse Event Reporting System (AERS)
Prosoft Clinical: Services and Capabilities (1/2)
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Service Capabilities
Clinical Operations and Trial Management
Pre-Study Activities• Site selection, qualification and training• Investigator and Vendor contract negotiations• Investigator meetings• Critical document collection• Drug supply coordination
On Study Activities•Project Management•Timeline and Budget Tracking•Monitoring•Medical monitoring (24/7)•SAE reporting•Query resolution through database lock•Drug reconciliation•Site Audits and QA
Medical Writing • Protocols• Clinical Development Plans• Investigator Brochures• Clinical Study Reports (submission ready)• IND/NDA/PMA Sections• Responses to Regulatory Authorities• FDA/Health Canada Meeting Briefing Packages• Publications• Posters for medical meetings• SOPs
Regulatory Strategy and Operations
• Product Development Strategy• Coordination /preparation of complete regulatory submissions• Interactions/negotiations with Regulatory authorities
Consultative Services
• Due Diligence• Program Design• Regulatory Authority Meeting Preparation & Participation• Advisory Board Planning & Participation• Life Cycle Management
Prosoft Clinical: Services and Capabilities (2/2)
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Therapeutic Area Trials Phase Patients Services
Allergy/Respiratory 20+ I – IV 3000+ Biostats, Data, Clinical Trial Mgt, CMC, Life Cycle Mgt, NDA, Nonclinical, Reg
CNS 11 II, IV 500+ Adaptive Design, Biostats, Data, DMC, NDA, PMA, Reg
Dermatology (Medical and Aesthetic)
20 I – IV* 2500+ ANDA, Biostats, Data, Clinical Trial Mgt, CMC, Life Cycle Mgt, Nonclinical, NDA, PMA, Reg
Heart Failure (device) 1 III 200 Biostats, IDE
HIV 3 I, III, IV 200+ Reg
HIV diagnostics 6 II/III 600+ Biostats, Data
Hypertension/Cardiovascular
8 II/III 2500+ Biostats, Data, Clinical Trial Mgt, Reg
Oncology 1 III 500 Biostats, DMC
Pain (device) 2 II 100+ Biostats, Data, Reg
Vaccine 6 I/II 400+ Biostats, DMC
Women’s Health 1 II 200+ Biostats, Data, Clinical Trial Mgt, CMC, Life Cycle Mgt, Nonclinical, Reg
Clinical Trial Experience
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The Prosoft Clinical Team has extensive hands-on experience and a successful product development track record.
We provide efficient, cost-effective services for all phases of your development program.
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Contact Information:
Dror Rom, Chairman and PresidentEmail: [email protected](p) 484-580-8162 x 302
Michael Nordsiek, CEOEmail: [email protected] x 310
Ayala Rom, Director of MarketingEmail: [email protected](p) 484-580-8162 x 314
Web: www.prosoftclinical.com