Implementing your non-clinical development plan
Our support doesn’t stop once your development plan is ready.
We help you select the right GLP compliant CRO for your project, from writing requests for proposals and helping you compare the offers, through to on-site audits that provide you with peace of mind.
We then manage the service provider for you, reviewing study plans, and reports and ensuring that the right studies are delivered at the right time to prevent costly delays.
We proactively coordinate and communicate with all the stakeholders to
ensure effective delivery of your project, on time and on budget.
You gain the reassurance that your non-clinical development is in safe hands.
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.