Nonclinical Drug Development Operations
Our team provides the operational support your company needs to turn strategy into data while ensuring outsourced studies are conducted in alignment with company priorities.
Overview of Nonclinical Drug Development Operations
Our Nonclinical Drug Development Operations teams work together to support the planning, conduct, and reporting of nonclinical pharmacology, DMPK, and toxicology studies, ensuring that timelines for data are clear and that emerging data from studies are presented in the appropriate context for decision making and regulatory applications.
Aclairo offers support consistent with client needs:- Aclairo can provide study monitors, toxicologists, senior strategists, DMPK/TK expertise, and pathology support. Work can be distributed to minimize client costs.
- Day-to-day communication with CROs to maintain timelines and scientific rigor in protocol development, study execution, and reporting
- On-site toxicology study monitoring (as requested) and virtual or on-site laboratory qualification
- Timely updates on study progress and protocol amendments
- Clear explanations of emerging data
- Regular updates to project teams
Timing of Nonclinical Drug Development Operations Support
Aclairo aims for flexibility in helping our clients succeed, so we can be there from the initial stages of study planning and vendor selection or jump in mid-study to alleviate bottlenecks for active programs.
Consider getting additional operational support:- When managing multiple CROs or external laboratories
- When internal teams need additional operational support
- When internal teams lack toxicology or pathology expertise
- When timelines for key data delivery are tight and tied to clinical study initiation
- When emerging data must be quickly interpreted in context for decision making
Expertise in Nonclinical Operations
What sets Aclairo apart is our depth of expertise. Our specialists bring decades of combined experience, ensuring that every project benefits from the best knowledge in the field.
- Experience across GLP and non-GLP environments
- Up-to-date knowledge of CRO capabilities and the best study directors at each site
- In depth practical knowledge of common pitfalls in toxicology studies
- Expertise in risk mitigation in protocol development to ensure smooth study conduct
- Cross-functional scientific expertise (toxicology, pharmacology, DMPK/TK, pathology)
- Deep understanding of regulatory expectations and study design
Our Nonclinical Operations Process
- Understanding program strategy and designing a study to meet team objectives
- Generation of a study outline to send to vendors
- Vendor selection (compilation of quotes and capabilities) and laboratory qualification (if needed)
- Study initiation and monitoring (on-site or remote)
- Ongoing data review and interpretation, including standing meetings as needed
- Communication and reporting to project teams
- Final report reviews and study closeout
Related Services
Frequently Asked Questions
- What do you mean by nonclinical drug development operations? We handle day-to-day communications with CROs (keeping sponsor contacts in the loop) and ensure that study activities stay on schedule and are conducted in accordance with sponsor priorities and protocol. This can also include toxicology program management, where we act as the toxicology lead for your program.
- What does study monitoring include? Study monitoring includes protocol development, correspondence throughout the study including issue resolution, monitoring visits (if required), in-life and post-study data reviews, report reviews and comment resolution, and report finalization activities, always keeping regulatory implications in mind.
- Can Aclairo act as the sponsor representative on my study? Yes, we do this frequently, but ideally there is also a sponsor company employee as a sponsor representative to approve budget changes.
- Can Aclairo contract with the CRO directly to conduct a toxicology study? No, we support studies that are contracted between sponsor companies and CROs.
Discover how Aclairo can support your nonclinical operations with tailored reports and expert-driven recommendations.