Drug Development consists of a multitude of complex and interconnected pathways and processes. All is complicated by a long list of rules and regulations set forth by the regulatory and other external bodies and legislators. Accelsiors does not limit its services to the conduct of clinical studies but always keeps the complete development strategy in mind. Irrespective of the scope of work, Accelsiors will boost the evolution of product. We will help you to find the shortest way through this “jungle of rules and guidelines”. We will consult you on your basic strategy, finding the direct road to success. We will analyse your existing processes and trouble-shoot if needed. By eliminating various unexpected road-blocks, we clear the way to proceed in a time- and cost-efficient manner.
Accelsiors CRO & Consultancy Services offer custom made expertise to help you develop your product portfolio. We boast a real “hands on” experience in drug development covering all aspects of this complex process.
We will map out a complete development program, “from cloning to filing”, including budgets, feasibility studies, pre-clinical, clinical development, preparation of the regulatory dossiers and more.
Accelsiors strives to bring your product to the market in the most cost-effective and timely manner, since the reduction of time to market is one of the key objectives in modern drug development.
In short, you can count on our high quality services in all stages of your drug development at competitive prices.
We offer the services listed below and more:
- Consultancy services in drug development with special focus on Innovative Biologics and complex Biosimilars
- CMC
- Consultancy and non-clinical plan development
- Clinical development plan preparation
- Regulatory strategy development and liaison with regulatory agencies
- Regulatory briefing package compilation
- Pediatric Investigation Plan (PIP) development
- Risk Management Plan development
- Annual safety report
- Clinical Services (Phase I – III)
- Trial design/protocol development
- Regulatory Management
- Trial Management and monitoring
- Onsite support through experienced SSCs outsourcing
- Full logistic support for the trials (import –export, IMP destructions, management of central reading facilities)
- Paper based and electronic record management
- Pharmacovigilance and medical monitoring
- Full Quality Assurance Services
- Biometrics
- Data Management (Both paper based and eCRFs)
- Statistics
- PK analysis
- PK/PD modeling and simulations
- Medical Writing and publishing