Integrated Drug Development
Given the current and foreseeable economic environment, companies from early stage and emerging biotechs to large pharmaceutical firms are being forced to do more with less. In an effort to reduce and/or minimize direct expenditures, outsourcing has become integral to many companies development strategies thereby eliminating the need to incur long term funding commitments for infrastructure. Numerous options now exist for outsourcing but too often lack integration resulting in limited productivity gains. To address this issue there is a paradigm shift underway in drug development by some in the pharmaceutical industry from what was a FIPCO (fully-integrated pharmaceutical company) model to a VIPNET (virtually-integrated pharmaceutical network) model. Creation of novel business arrangements between sponsors and vendors are giving rise to accelerated development in a virtual world where realization of both time and cost savings is clearly apparent.
Aptuit Consulting is uniquely positioned to serve the industry in an integrated and virtual capacity through its broad and extensive service lines providing expertise in all facets of drug development.
Our Aptuit INDiGO and First in Human programs can leverage all the service offerings of Aptuit. These activities are led and driven by Aptuit Consulting’s experts and are focused on providing key deliverables in an efficient and productive manner.
Our Drug Development Programs include:
Aptuit INDiGO and First in Human programs
- Rapid regulatory filing and Phase 1 data in 8 to15 months
- Premium products and program management at a fixed price & fixed timeline
- Preclinical and Clinical Trial Material
- Regulatory submission for First in Human trials
- Phase 1 data
- Leadership by an internal team of industry-seasoned drug development experts
- Customizations to meet your needs, with or without API supply
- Access to and leverage of integrated in-house (Aptuit) capabilities, including world-class preclinical toxicology, clinical supplies, regulatory documentation and electronic regulatory report preparation support services
- Benefits from streamlined scientist-to-scientist communication
The team at Aptuit Consulting has expertise in all areas critical to early development success and integrates these in a manner allowing for the more efficient and productive development of drugs. Employing such a model limiting fixed expenses has been shown to save a company millions in development costs, whilst not compromising on speed.