Premier Partners
Optimize your nonclinical & early-stage clinical. Premier Partners provides managed nonclinical laboratory solutions to streamline and advance drug development programs for emerging biopharma companies.
Our Solutions
Serving as an integrated extension of your team, Premier Partners delivers a better way to optimize your outsourcing:
For even the most experienced drug development teams, choosing the right strategic partners can be a challenge. Program success is at stake, and you need partners you can trust to validate the safety and efficacy of your molecule. A collaborative, proactive approach is key to managing risk and keeping your timeline on track.
As you evaluate potential partners, you find yourself asking:
- Will this partner help execute the right studies? At the right time? For the right price?
- What are the risks and how will I know if our study is on track?
- Who will oversee our studies and how often should I be on-site to monitor progress?
Smart Study Design
Partner with multi-disciplinary experts to optimize study designs and ensure your drug development plan minimizes risk and cost.
Tailored Nonclinical Laboratory Selection
Find reliable nonclinical laboratories through our network of trusted partners to support your late discovery through early clinical study needs.
Comprehensive Management
Stay on track with program oversight including on-site monitoring and study reporting conducted with your best interest in mind.
For Sponsors
Drive Program Success from the Start
Our experienced team of drug development experts is committed to helping you reach critical decisions faster. With your research goals in mind, we provide study design, nonclinical laboratory selection, and program management solutions to execute a full range of GLP and non-GLP preclinical evaluation studies and advance your program to first-in-human studies.
Preclinical Research
- ADME
- Animal efficacy
- Bioanalysis
- Candidate selection
- Discovery pharmacokinetics (PK)
- Dose formulation analysis
- Drug characterization
- hERG and genotoxicity
Nonclinical Toxicology
- IND and NDA enabling programs
- Bioanalysis
- Carcinogenicity
- Developmental and reproductive studies
- Dose range finding and repeated-dose studies
- Genetic toxicology
- Pathology
- Pharmacokinetics (PK)
- Safety pharmacology
- Specialized studies
Advance Seamlessly into the Clinic
Transition into the clinic and set your sights on moving to and through proof of concept with CMC and early clinical support.
CMC
- Formulation development
- Full process development and manufacturing
- Packaging and distribution
- Stability studies
Early Clinical Development
- Bioequivalence
- Food effects
- Phase 1-2
- Single ascending dose and multiple ascending dose (SAD & MAD)
Experience
Our team brings diverse scientific and drug development expertise in areas including ADME/PK, bioanalysis, CMC, pharmacology, and toxicology. We leverage Premier Consulting’s Quality Management support capabilities to stay at the forefront of quality and compliance standards. The compounds and studies we support include:
Compounds
- Antibodies
- Drug conjugates
- Oligonucleotide
- Peptides
- Proteins
- Small molecules
- Vaccines
Studies
- Acute to chronic
- All major indications
- All major routes of administration
- All major species including NHPs
- Non-GLP and GLP
Sponsors Contact Us
For Consultants
Partnering to Achieve Sponsor Success
Premier Partners works with drug development consultants to provide high-touch solutions that increase your bandwidth to focus on critical program design and development strategy decisions.
Consultants who work with Premier Partners enjoy:
- End-to-end RFP management
- Tailored study management support including on-site monitoring and study documentation
- Access to audited, GxP-compliant nonclinical laboratories, CMOs, and clinical sites
Consulting partnerships are customized to suit your needs. Here is one example of how we currently partner with consultants:
| Responsibility | You | Premier Partners |
| Program Design | Primary | Secondary |
| RFP Management | • | |
| Proposal Review | • | |
| Study Plan / Protocol Review | • | • |
| Communication with Laboratory | • | • |
| Monitoring | As desired | • |
| Data Review | Primary | Secondary |
| Report Review | Primary | Secondary |
Interested in customizing your solution? Contact us to learn more about our solutions for consultants.