Competencies Clinical Development Full-service Study Execution
Early Phase Clinical Development
Phase I – Phase IIa studies
We offer a comprehensive set of solutions to support your early phase clinical development, whether this is a first-in-human or proof-of-concept study. Our solutions ensure a smooth and consistent transition from the non-clinical to the clinical phase of your drug candidate development based on science, regulatory compliance, and our company’s and people’s long-standing experience.
The majority of drug development programs fail in a very early phase. This failure could reasonably be controlled with the proper translation of non-clinical findings and the implementation of robust risk mitigation strategies. Let’s allow our dedicated teams led by seasoned pharmaceutical veterans to assist you in moving your product forward in this vulnerable phase.
In addition to the physical execution of early phase studies, whether in Phase I Unit or in Clinical Setting, we offer a broad range of supporting, complementary solutions, like expert advice in assay selection and validations (irrespective of whether analytical or antigenicity assessments), optimization of study design, use of pharmacological provocation tests, deep analysis and interpretation of PK/PD relationships, PK/PD modeling and simulations, in vitro in vivo correlations, early population PK modeling approaches, special medical monitoring, safety signal detection, always ensuring maximal scientific and regulatory compliance.
While planning, conducting, and analyzing your early-phase clinical studies, our primary goal is always to maximize the value of your early-phase clinical program through focused efforts in ensuring quality, scientific integrity, regulatory compliance, innovation, and program acceleration.
Discover how our solutions are merging unparalleled acceleration and quality in clinical trial delivery
Accelerated Delivery is Accelsiors’ experience-driven dynamic planning and operational model – the harmonization of our scientific expertise, wide reaching services, quality insights, advanced clinical research technology, proactivity and tailored collaboration approach.
Explore our powerful suite of solutions built to accelerate delivery of quality results in clinical drug development!
Building quality in design
Knowledge, experience, compliance
On the accelerated route of study delivery
Fully standardized contemporary project management
We offer a complete set of Early Phase Clinical Development Services to properly handle constantly moving elements of your first-in-humans and proof-of-concept studies:
- Clinical development planning / Protocol design with medical and scientific consultation
- PK/PD modelling
- Feasibility assessment
- Global regulatory affairs, strategies, facilitation, operation
- Global early-phase investigators network
- Study Start-up
- Clinical trial project management
- Recruitment and enrollment of healthy volunteers and special patient populations
- Site management
- Safety management, Pharmacovigilance
- Record management
- Data management
- Bioanalytical services and advanced biostatistics
- Vendor management
