Why Choose CSTI?
Since 1997 CSTI has been providing our life sciences clients with expert development management services across many asset types and therapeutic areas. CSTI delivers objective, vendor-independent strategic planning and advice, using industry-proven processes and tools with results-oriented teams. Additionally, clients needing to supplement their capacity receive access to our network of pre-qualified technical affiliates.
For Life Sciences Organizations:
Our flagship Development Management Services integrate all disciplines supporting asset development from candidate selection to commercialization, while our Clinical Trial Management services provide a cost-effective option for the execution of early-stage clinical trials and clinical trial management. Through our Advisory Services we offer our expertise to our clients enabling them to more effectively manage development internally.
We offer Due Diligence Services, providing an in-depth and objective assessment of the status of the asset and asset management, and the development and commercialization potential and strategy.
Providing extensive experience in managing the development process for a life science asset or asset portfolio including:
- Facilitate design or reset of strategic development plans; optimize plan to minimize development timeline and cost and align with commercialization strategy.
- Document development plan and commercialization strategy with identified go/no go decisions, and regulatory, technical, business and commercial risks
- Develop and track asset development forecast, and manage variances
- Identify asset milestones and deliverables, track status and manage variances
- Lead integrated, multidisciplinary, virtual development teams, typically involving the following technical experts: pharmacology, toxicology, regulatory, clinical operations, medical, CMC, research scientists, analytical and bioanalytical and commercial professionals
- Assist in qualifying and selecting vendors and technical personnel
- Advise on vendor contract structure and terms
- Manage vendor performance to contract and budget
- Design and implement operational infrastructure
- Train development team
- Provide standard, periodic reporting on the asset status to executive management and stakeholders
Clinical Trial Management
Engage a team combining best practices and proven experience to effectively manage clinical trials and produce quality data.
- Clinical study portfolio design; including study program optimization to minimize time and cost to achieve program milestones; prepare and maintain program forecast and timeline
- Clinical study design
- Analyze current clinical operations and provide recommendations for improvement and implement recommendations
- Clinical study execution in accordance with CSTI SOPs
- Manage multi-disciplinary clinical study team (i.e., statistics, medical writing, data management, documentation management and medical monitor)
- Establish clinical study/clinical program budget, and manage variances
- Develop and maintain clinical study/clinical program deliverables, and mitigate and communicate variances to team and stakeholders
- Assist in qualifying and selecting clinical research personnel or contract personnel
- Train clinical research personnel
- Advise on vendor contract structure and terms
- Manage vendor performance to contract
- Prepare clinical study documentation including: data collection tools, study protocols, consent forms, Investigator’s Brochure and study reports
Expert advice on drug, medical device development, business operations and business strategies including options and risk assessment.
- Clear and executable recommendations which CSTI or the client can implement
- CSTI Advisory Services are based on our experience providing Development Management and Clinical Management Services
- Assess current state against industry best practices in the following areas: development strategy, development team operations, clinical strategy, clinical operations and business operations
- Identify regulatory, technical, medical, business and commercial gaps and risks
- Provide industry-proven recommendations for improvement and a detailed road-map to future state
- Ongoing counsel on resolving strategic development, clinical or business issues as they arise
Assessment of target company's development, expertise, risk and market potential.
- Review target’s development strategy, development program operations, program status, expected timeline and budget, commercialization strategy and feasibility of commercial success.
- Identify potential regulatory, technical, medical, business and commercial gaps and risks
- Report results
Clients needing to supplement their capacity receive access to our network of pre-qualified technical affiliates. Our affiliates offer subject matter expertise in areas such as toxicology, pharmacology, formulation development, technical writing, clinical strategy and operations, regulatory strategy and operations, medical and commercial.