Flexible, real-world market access strategies help remove the obstacles that can limit patient access to your biopharmaceutical product or medical device. Our consultants can assist by addressing patient access issues such as pricing and reimbursement and insurance coverage.
A leader in biopharmaceutical product commercialisation, CRC provides unrivalled service excellence. Drive market access results and achieve market success with applied insight and efficient execution.
Expand patient access, improve adherence, and maximise penetration with:
- Patient Support Programs
- Persistency and Adherence Programs
- Risk Management/Risk Evaluation and Mitigation Strategies (REMS)
Plan your economic marketing strategy.
Resourceful consultants who are knowledgeable about complex reimbursement issues and current regulatory and legislative changes are just a phone call away. Having CRC consultants on your team means an automatic network of knowledgeable professionals.
We will help you make more informed decisions about pricing, customer support, and market positioning for your pharmaceutical, biotechnology, or medical device.
- Policy & Market Research
- Market Access Strategy
- Product Line Support
Capture and convey the value of your product.
CRC measures the patient-reported and economic benefits of your product, evaluating the results from various perspectives of those who can affect its success: health care providers, third-party payers, government regulators and patients. We will analyse existing data or design and conduct our own studies to demonstrate your product’s clinical and economic value to decision makers.
- Pricing studies
- Systematic literature reviews
- Global value dossiers
- Customised submissions to PBAC
- Patient reported outcomes studies
- Health economic evaluations and modelling
- Claims data analyses
- Observational studies
- Utility assessment studies
- Publication strategy, abstracts, and manuscripts
Unique Operational Insights
Regulatory scrutiny doesn’t end with product approvals. Once products are approved for use in the “real-world”, CRC is there, before and after approval, to provide clinical and therapeutic solutions for programs necessary to monitor safety and support product use in larger and more diverse populations.
Depth and Breadth of Experience:
- State-of-the art approaches for creative and compliant solutions
- Analytical and technical resources
- Interdisciplinary teams with deep therapeutic insights and expertise
- Delivery of consistent, high-quality results
- Registration filings
- Down schedule and filing
- Product safety & Pharmacovigilance
Engage a team of global safety experts for safety reporting and post-marketing surveillance. Build on a foundation of extensive experience and expertise. Our teams have backgrounds and training in safety, clinical research, data management, and regulatory affairs.
- SAE reporting for phase II, III, IIIb and IV clinical trials
- Safety call intake centers (receipt of initial calls, initiation of electronic or paper reports/ notifications)
- Medical review of triaged reports
- Literature searches
- Safety data extraction from legal documents
- Data entry into safety databases
- Data quality checks
- Medical and consumer follow up
- Preparation of regulatory and safety reports
Signal identification is determined by your needs and volume. CRC uses manual and automated processes and strategies to assess signal detection which include:
- Case report observations from the literature
- Assessment of individual reports or clusters of reports in spontaneous reporting systems
- Signals detected in observational databases and clinical trials
- Safety database queries using Standardised MedDRA Queries (SMQs)
- Maintain query results
- Perform case series analysis-assess association with specific risk factors
- Conduct FOI analysis against FDA AERS or WHO Vigibase databases (if necessary) to examine disproportional reporting ratios
- Evaluate event data, document as necessary
- Medical review of reports
Phase IV studies are an important tool of commercialisation strategies and driven by the changing regulatory environment, post-market commitments and ever-growing concerns over safety.
Chart Your Course with CRC
- Compelling science and solid epidemiological data and principles to help you manage and drive your product within an evolving and dynamic market
- Pragmatic Strategy for post-marketing life cycle management
- Long-term outcome studies
- Traditional prospective and retrospective epidemiological studies
- Post-marketing regulatory commitments
- Real-world effectiveness, tolerability and adherence studies
- Patient-reported outcomes
- Chart review studies
- Claims data analysis
- Studies designed to gauge use in typical patients
- Comparator or product differentiations
- Novel interventional designs (population-based designs)
- Studies to support promotional claims