Industry Provider Profiles
REGISTRAT-MAPI

• Real World. Real Solutions.
• Full Service Late Phase Research
• Study Services
• Service Outsourcing
• Expertise
• Late Phase Focus
• Technology
• Global Locations
• Contact Company

Real World. Real Solutions.

At REGISTRAT-MAPI, we provide strategic and operational solutions for our clients in the design and implementation of Late Phase studies. REGISTRAT-MAPI is the pharmaceutical industry’s largest global CRO dedicated exclusively to real world clinical research. With more than 450 experienced professionals, REGISTRAT-MAPI has served the biopharmaceutical and medical device industries for more than 20 years. Our mission is to partner with our sponsors to conduct quality research, advance scientific knowledge, gain clinical insights, and optimize the effectiveness and safety of medical products.

Full Service Late Phase Research

REGISTRAT-MAPI is an established leader in navigating the complex and evolving landscape of global Late Phase research. With offices in Europe, North America, and Asia, we will guide you through strategic and practical issues from project conceptualization and design, to global execution in the real world.

Study Services

Study Services

• Investigator Targeting & Recruitment
• Study Feasibility
• Concept to Protocol Development
• Regulatory Strategy & Interactions
• Site Management & Monitoring
• Project Management
• Case Report Form Design
• EC & IRB Regulatory Submissions
• Document Management
• Call Center
• Data Management
• Programming/Biostatistics
• Safety Management
• Patient Data Collection

Service Outsourcing

Epidemiology

• Market Forecasts
• Literature Reviews
• Feasibility Assessment
• Study Strategy & Design

Programming & Biostatistics Safety

• Case Processing
• AE Database Management
• Regulatory Reporting
• Signal Detection

Expertise

REGISTRAT-MAPI experts are your direct link to the latest views and solutions associated with Late Phase research. Our team is comprised of seasoned professionals with broad and deep knowledge. Importantly, that expertise is honed from hands-on involvement in the practical challenges of designing and managing Late Phase research. These are not "ivory-tower" resources but rather individuals who bring a current understanding of one of the most rapidly evolving areas in pharmaceutical development.

Late Phase Focus

What are Late Phase Studies?

Late Phase or Peri-approval studies are conducted prior to product approval (Phase IIIb) and following product launch (Phase IV) to demonstrate product effectiveness, safety, and acceptance. Although generally not randomized or controlled, Late Phase studies are conducted with the same regulatory and data quality standards as registration trials. As a result, analyses and publications generated from these validated data add insight to the real-world use of a product or demonstrate evolving practice patterns.

Late Phase studies direct future product development, manage risk, and provide commercial opportunities. Increasingly, the FDA is granting product approval on a conditional basis-estimated to be 75-80% of new chemical entities-requiring that a Sponsor conduct post-approval surveillance of the product. As a result, long-term tracking of patients in a real-world clinical setting provides valuable ongoing safety information for risk management. Additionally, Late Phase studies can target particular therapeutic areas or populations where relevant clinical data are required to ascertain the effectiveness and utilization patterns of a product. Managed care organizations, healthcare providers, and consumers all have an interest in obtaining real-world clinical, economic, and humanistic outcomes data to improve the quality of patient care.

A Late Phase study is an integral component of the commercialization effort for a product because it impacts multiple aspects of ongoing clinical and commercial support. A program such as a product registry is a systematic effort that encompasses and integrates the perspectives and objectives of Clinical, Safety, Marketing, Sales, Regulatory, and Legal in the commercialization process.

Types of Late Phase Studies:

• Phase IIIB Study-completion of registration studies / safety / experience
• Phase IV Study-comparative / label extension
• Product registries
• Disease registries
• Pregnancy registries
• Pharmacoepidemiologic studies
• Post-marketing safety surveillance
• Large Simple Safety Studies (LSSS)
• Risk Management Programs (RMP)
• Clinical experience trials
• Patient Reported Outcomes (PRO)
• Health economic outcomes
• Compliance / adherence
• Medical / Product utilization
• Expanded Access Programs (EAP)

Value of Late Phase Studies:

• Generate clinical effectiveness data
• Support & strengthen the product safety profile
• Provide "real-world" clinical, economic, humanistic outcomes
• Provide a supportive environment for treating physicians
• Impact quality of patient care
• Develop "best practice" guidelines, and standards of care
• Generate hypotheses
• Develop sub-studies
• Provide data for abstracts, manuscripts, and society meetings
• Integrate Clinical, Safety, Marketing, Sales, Legal, and Regulatory in the commercialization process
• Provide a value-added service & demonstrate responsiveness to customers
• Demonstrate a commitment to:
• Patient care
• Quality improvement
• Education of healthcare providers
• Accelerate product adoption to achieve rapid peak sales & maximize product potential
• Identify under-treated patient populations
• Characterize evolving treatment patterns
• Influence market expansion & product penetration
• Promote product retention & compliance
• Identify factors impacting prescribing decisions
• Identify issues related to product use
• Generate clinical data on a product to drive market leadership
• Characterize unsolicited off-label product use
• Evaluate data to develop targeted sales & marketing strategies
• Use objective data to drive product life cycle planning
• Obtain competitive intelligence on other manufacturers' products
• Maximize communication opportunities with key customers

Technology

REGISTRAT-MAPI technologies are seamlessly integrated, as project requirements dictate, to provide optimal project-specific solutions. REGISTRAT-MAPI professionals research new technology and evaluate ways to enhance current technology for ease of use in clinical studies. Developers and support staff have the requisite experience to guide requirements and implement technologies for large clinical and observational studies.

REGISTRAT-MAPI validates all technologies to maintain compliance with appropriate regulatory guidelines. SOPs guide Validation Specialists working in cooperation with the Quality Assurance department to ensure proper standards are met or exceeded. The REGISTRAT-MAPI Software Development Lifecycle allows for flexibility in the creation of new systems while maintaining a high level of quality.

All systems are developed, validated and maintained in compliance with the FDA’s Proposed Rule on Electronic Signatures (21 CFR Part 11), Electronic Records. REGISTRAT-MAPI also validates in accordance with regulatory guidelines.

Site Management Technologies:

• REGISTRAK
• Portal Technologies

Data Collection Technologies:

• EDC System Design / Implementation
• Electronic Patient Reported Outcomes (ePRO) Solutions
• Interactive Voice Response System (IVRS)
• REGISTRAT-MAPI Electronic Data Capture
• Fax Scanning

Reporting Technologies:

• Data Visualization Technology

Global Locations

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