Clinical Development Architect
Services
Opial accelerates, secures and strengthens the management of your therapeutic innovation projects. Our approach is based on multidisciplinary expertise and effective coordination of all stakeholders involved in clinical development.
Opial develops customized solutions based on its experience, its network of experts and opinion leaders, and its ability to manage risks and emergency situations.
Management of therapeutic innovation projects
As part of the management of clinical activities, Opial provides the interface for therapeutic innovation projects in all areas of development: regulatory affairs, preclinical and clinical research, manufacturing, quality, vigilance, market access… according to your schedules, budgets and therapeutic objectives. Thanks to its multidisciplinary approach, Opial is able to coordinate all the parties involved and closely monitor the progress and cost of the project.
- Schedule management
- Contract and budget management
- Quality management
- Cost control and optimization
- Team building / Project organization
- Reports to the Board of Directors
- Coaching / mentoring
Clinical development
Opial optimizes your clinical development strategies according to operational and regulatory constraints and supports your teams on a daily basis to facilitate and clarify decision-making. This intervention is based on our experience and the regular mobilization of expert panels and clinical opinion leaders. Particularly suited to innovative structures with little or no prior clinical experience, it provides support tailored to your needs.
- Management of clinical activities / Drafting of protocols
- Surveys and bibliographies
- Medical and scientific relations with KOLs / Development of investigator networks
- Overall project coordination
- Management of service providers (QA, market access, pharmacovigilance, CRO, regulations, DM / Stat…)
- Risk management
- Coordination of regulatory projects (ODD, CTA, Pediatric Investigation Plan, etc.)
- Temporary authorizations for use / Early Access Programs
Clinical operations
Opial supports you in the operational implementation and supervision of your clinical trials by defining your clinical protocols to ensure feasibility, optimize costs and facilitate regulatory validation: methodological choices, bibliographical studies and research, definition of clinical evaluation criteria, feasibility studies, risk analysis, sample calculation, biostatistical analysis, search for funding, etc. Opial oversees the implementation of project management tools integrating all facets of clinical projects to guarantee data integrity within the framework of good clinical practice, including: protocol, eCRF, study kits, resources, training and communication… Opial draws on over 20 years’ experience to work with your teams, coaching them, advising them and motivating them. Opial also organizes the sourcing and management of outsourced operations, in particular CRO (Contract Research Organization) activities.
- Supervision of clinical operations, budget/planning and operational management of clinical development activities, including project management, monitoring, data management, statistics, drug supply chain, regulatory affairs, risk management, pharmacovigilance, quality and market access.
- Setting up and managing clinical trials: protocol design, identification of investigators
- Feasibility study / site selection
- CRO outsourcing / supplier management (QA, central laboratory, pharmacovigilance, regulatory affairs, biometrics, CMO, IWRS…)
- Project gap analysis and remediation management
Interim management
Within your organization, Opial supports you in management emergencies to maintain your operations.
- Clinical team management
- Purchase of services for conducting clinical trials, assistance in selecting CROs
- Management and coordination of service providers, outsourcing of ad hoc activities
- Project and program management
- Project rescue and recovery
- Risk management
- Risk analysis
- Action plan implementation and follow-up