Reaching the clinic starts with good planning
Your non-clinical development programme should show the efficacy, mode of action, and toxicity profile of your drug. You need to decide which models will provide meaningful data, in what sequence the work should happen, what the regulators will expect, and where any gaps could delay or even derail your clinical trial application.
We help you answer these questions early. Working alongside your team, we build a scientifically sound, regulatory-informed, and practical development plan around your product, target product profile and intended clinical pathway.
The result is a clearer route to the clinic, with priorities defined and risks made visible before they become delays.
Development strategy & planning services overview
Our team of experts will define a bespoke, regulatory-compliant development plan tailored to your product, your strategy and your needs.
Pharmacology and toxicology
Our experts help you determine the necessary pharmacology studies and required toxicology, toxicokinetic and safety pharmacology assessments in appropriate species. Together, we establish the bioanalytical methods and testing criteria needed to generate relevant, regulatory-ready evidence.
Regulatory pathway
Our regulatory experts help you develop the strategy and plans, including scientific advice and pre-IND meetings, orphan drug or fast-track designations, and CTA or IND applications. Each step is aligned with your wider development plan.
CMC development
Our experts help you define the production scale, formulation requirements and control strategy. Working alongside your team, they align these elements with the wider development plan to support manufacturing and regulatory submissions.
Development roadmap
Our team helps build a detailed Gantt chart showing realistic sequencing, key dependencies and estimated costs. This provides a clear view of the development timeline, budget requirements, upcoming milestones and critical decision points.
From development plan to delivered non-clinical studies
Our help doesn’t stop once your development plan is done.
We remain alongside your team providing hands-on, efficient and flexible operational support to implement the plan.
Service provider selection
Service provider identification
Our team draws up an impartial list of appropriate service providers, based on your programme requirements and the specific expertise needed.
Service provider identification
RFP preparation
Our expert drug developers prepare clear, detailed requests for proposals so service providers and specialist toxicology CROs can respond accurately to your requirements.
RFP preparation
Proposal review
We liaise with each service provider to obtain complete, optimised and comparable proposals and costings, helping you make a well-informed choice.
Proposal review
Toxicology CRO audit
Our QA team carries out a GLP audit of the selected toxicology CRO to confirm compliance with the applicable requirements.
Toxicology CRO audit
Service provider management
Study planning
Our experts review each study protocol to ensure every experiment measures what matters, without cutting corners or adding unnecessary rounds of testing.
Study planning
Study management
Working with service providers, we monitor progress and results, identify problems early and propose regulatory-compliant solutions that keep your project moving.
Study management
Document review
Our experts critically review study reports for scientific quality, consistency and regulatory compliance, identifying gaps that should be addressed before finalisation.
Document review
Project oversight
Effective project oversight depends on clear coordination across every service provider involved. Our team keeps responsibilities, deliverables, timelines and expectations aligned, so everyone understands what needs to happen and when.
Progress, budgets and risks are monitored throughout the project. Emerging issues are made visible early, giving your team time to assess the impact and agree on practical solutions before they affect delivery.
Clear, regular updates give your leadership team and board an accurate view of progress, key decisions and next steps. This supports timely decision-making and keeps the project moving in the right direction.
Support across product types: the development plan is adapted to the product.
Non-clinical development strategy is highly dependent on the nature of the product, which is why our development plans and operational support are carefully tailored to each project’s needs. The development plan should never be treated as a standard checklist.
Our specialists support programmes across:
- Small-molecule new chemical entities
- Peptides and proteins
- Antibodies and antibody-drug conjugates
- Nucleic acid-based products
- Viruses and bacteria, including genetically modified organisms
- Gene, cell and tissue therapies
- Advanced therapy medicinal products (ATMPs)
- Implantable medical devices
Experience across therapeutic areas
One strategy from non-clinical development to the clinic.
Non-clinical decisions influence CMC development, regulatory strategy and clinical design. Clarenta connects these disciplines so that each part of the programme supports the same development objective.