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As the CRO industry has evolved, many of the therapeutic area expert teams they hired have been disbanded in favor of an orientation that actually has made them less able to meet the unique needs of smaller pharmaceutical companies. This approach has enabled the large CROs to market to large pharmaceutical companies across therapeutic areas. They assume that large pharmaceutical companies have the in house staff to address the novelty and complexity of new molecular entities and new therapeutic indications.
Best Practice fills the void in services and service orientation available to smaller and non-US based companies up to the point that they may require a CRO to manage large scale multi-site trials. At that point, Best Practice can help these companies select from the services offered by large and small CROs, and assist the client to manage the CRO relationship, including the identification of the highest quality and most cost efficient sites in each therapeutic area across CNS drugs.
Best Practice’s drug development services and expert opinion leadership enable our clients to meet their goals and timelines for CNS drug development. With a focused and well-executed development plan, each client is positioned to address its most important audiences: employees, regulators, investors and potential pharmaceutical partners.
Pre-approval support for all phases of drug development
- Drug development plan preparation
- Opinion leadership consultation
- Scientifically driven project management
- Regulatory advice
- Investigator brochures
- CRO selection and oversight
- Site identification
- Rater training
- Abuse liability study design and implementation
- Drug abuse risk management program design for FDA review
Post-marketing design and consulting services
- Phase IV clinical trial design and implementation
- Retrospective analyses of specific managed care and national healthcare databases to assess long term drug safety and effectiveness
- Consensus conference organization and sponsorship in areas of clinical controversy
- Application of innovative technologies to improve outcomes assessment in clinical trials
- Abuse liability and risk management program support, implementation and surveillance
- Post-marketing support and advice
Scientific evaluation for business and legal purposes
- Scientific due diligence
- CNS market analysis
- Litigation support
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