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CLINICAL DEVELOPMENT
Designing, conducting, and managing clinical studies
The Analgesic Clinical Unit (ACU) focuses on single-site proof-of-concept studies in patients with chronic pain to assist companies with expedited drug development. We also can participate in phase II and III multi-center studies and provide additional CRO services such as project management and data management, including data analysis and biostatistical support. The ACU has a special interest in studies that advance clinical research methods and assessments and often collaborates with our Psychometrics Unit.
CONSULTING
Advising clients on analgesic drug development and regulatory strategy
The Consulting Unit provides strategic insight to companies for their drug development programs. After thoroughly researching and understanding your needs, we assemble a customized team of internal personnel and external associates to provide the best input available on issues related to drug development with a primary focus on clinical pharmacology, clinical development plans, clinical study design and implementation (including proof of concept studies), regulatory strategy, biostatistics, and risk management. We also provide specialized strategic support for interactions with FDA (regulatory filings and preparation for advisory committees) and investors (due diligence and fund raising) as well as strategic marketing analysis (e.g., expanded indications, clinical benefits/ opportunities).
OUTCOMES & PSYCHOMETRICS
Devising and testing innovative assessment tools to support analgesic development
The Psychometrics Unit is focused on providing improvements in pain measurement and assessment methodology. Our goal is to increase efficiency in the development and assessment of analgesic treatments and help clients define unique benefits of their treatments. Our core team incorporates medical and psychological expertise into a psychophysical approach to pain. We have extensive experience with measure development and validation and our extensive network of consultants allows us to provide topic-specific expertise to a wide range of areas. We provide services in the following areas: 1) measure development and validation, 2) experimental design consultation, 3) patient screening assessment tools, 4) outcomes consulting 5) psychosocial assessment, 6) psychophysical profiling, and 7) innovative statistical analyses.
RISK MANAGEMENT
Creating plans to mitigate risk
The Risk Management Unit helps pharmaceutical companies craft and execute risk evaluation and mitigation strategy (REMS) plans that achieve tangible public health goals and prepare for NDA submission. Our risk management services include product risk assessment, strategic planning, surveillance strategy design, and briefing package support. We provide complete medical writing services for REMS Plans, REMS Supporting Documents, and support materials to accompany REMS submissions. We have unique insight into the challenges facing opioid manufacturers, have written or contributed to multiple risk management plans, and have recently completed a REMS Plan for an opioid analgesic.
SCIENTIFIC COMMUNICATIONS
Communicating to the scientific and regulatory community
The Scientific Communications Unit creates accurate, insightful, and evidence-based publications for the peer-reviewed medical literature. Analgesic Research publications meet all current journal guidelines and standards as well as industry compliance regulations. We also exceed all current standards by putting all papers through Enhanced Peer Review™, which consists of review by a standing expert panel in pain management and biostatistics. All authors on papers or supplements developed by Analgesic Research must meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Scientific Communications also supports all other units within Analgesic Research to generate protocols, clinical study reports, and publications reporting original research.
LICENSING & ACQUISITIONS
Helping clients meet their licensing and acquisition needs
Product licensing is a rigorous, systematic process. We work closely with the client to develop the right business strategy and then provide a comprehensive and tailored suite of services, including:
- Market assessment
- Identification of available opportunities
- Due diligence for in-licensing opportunities
- Development of out-licensing/acquisition material to inform prospective partners
- Contacting companies using our network of biotech and pharma contacts
- Face-to face meetings to present/evaluate opportunity
- Advice on negotiation and principal contract terms
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