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: d.rom@prosoftclinical.com(p) 484-580-8162 x 302

Michael Nordsiek, CEOEmail: m.nordsiek@prosoftclinical.com484-580-8162 x 310

Ayala Rom, Director of MarketingEmail: a.rom@prosoftclinical.com(p) 484-580-8162 x 314

Web: www.prosoftclinical.com