Nonclinical Sciences
The main goals of preclinical development are to determine a starting, safe dose for first-in-human studies while assessing the potential toxicity of biopharmaceutical drugs, medical devices and diagnostics.
NGT BioPharma Consultants collaborates with clients to support and integrate multidisciplinary scientific evaluations essential for characterizing a new molecular entity’s properties, enabling progression into the clinic and initiation of first-in-human (FIH) trials. These evaluations encompass pharmacology for safety and efficacy, toxicology, pharmacokinetics, and the CMC attributes that characterize the manufacturing processes. Recognizing the interdependencies among these studies, we leverage our collective expertise to design nonclinical plans that support the drug candidate’s intended clinical indication and development pathway.
Services
To support your team in navigating the scientific complexities of drug development, NGT possesses extensive subject matter expertise contributing to a multi-disciplinary team who can both advise on or lead the development of strategies and experimental approaches needed to advance drug candidates through nonclinical (preclinical) and early clinical evaluations. Our services include:
Strategy
- Nonclinical strategies to support clinical development plans and the proposed indication
- Exploratory and investigative toxicology strategies
- Nonclinical study alignment with regulatory strategies
- IND-enabling toxicology study strategies and interpretation of results, including e.g., pathology, PK/PD, together with long-term and specialty toxicology evaluations
Study Support
- Pharmacokinetic and metabolism profiling
- PK/PD evaluation, preliminary human dose/exposure projections and safety margins
- Nonclinical pharmacology and translational assessments
- PK/PD modeling support and evaluate predictive models
- Coordinate and oversee the outsourcing of laboratory nonclinical studies
DIGITAL SERVICES EXPERTISE
OUR SERVICES INCLUDE:
- STAFF AUGMENTATION
- Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets such as computer systems validation experts, business analysts, product managers, and Agile Scrum masters.
- SOFTWARE DEVELOPMENT AND MARKETING CONSULTANCY
- Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.
- Marketing support to position digital products with the right decision-makers.
- DIGITAL STRATEGY CONSULTANCY
- Benchmarking current digital capabilities against industry best in-class and highlighting gaps and opportunities.
- Reviewing and critiquing existing digital strategies.
- Facilitating the creation of a digital strategy.
- Work-flow reinvention and disruption to exploit digital capabilities.
Talk to NGT BioPharma Consultants to learn how we can deliver a customized solution to address your project needs.
DIGITAL SERVICES EXPERTISE
OUR SERVICES INCLUDE:
- STAFF AUGMENTATION
- Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets such as computer systems validation experts, business analysts, product managers, and Agile Scrum masters.
- SOFTWARE DEVELOPMENT AND MARKETING CONSULTANCY
- Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.
- Marketing support to position digital products with the right decision-makers.
- DIGITAL STRATEGY CONSULTANCY
- Benchmarking current digital capabilities against industry best in-class and highlighting gaps and opportunities.
- Reviewing and critiquing existing digital strategies.
- Facilitating the creation of a digital strategy.
- Work-flow reinvention and disruption to exploit digital capabilities.
Talk to NGT BioPharma Consultants to learn how we can deliver a customized solution to address your project needs.
Working with Big Pharma Globally
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Get in touch
For additional information pertaining to the Nonclinical Sciences service area, please contact Mike Placke or our CEO Michael O'Brien via the contact information provided below. Alternatively, please fill out the Inquiry form and we will get back to you within 48 hours.
