Which partners should you choose for preclinical and clinical development?

Developing a new innovative drug is a major challenge for any organization. For a biotech start-up or a large pharmaceutical company, bringing a therapeutic molecule from discovery to commercialization, including preclinical development, is a long, costly, and complex process.

In this competitive environment, complete internalization of the value chain has become rare. Outsourcing is now an essential operational lever. Choosing the right partner goes beyond a simple customer-supplier relationship. It is above all a strategic decision that directly impacts data quality, meeting deadlines, and ultimately obtaining regulatory approval.

 

 

Understanding needs: from early stages to patient administration

Before entering into any collaboration, it is essential to precisely define the technical and regulatory requirements, which vary considerably depending on the stage of development.

 

The preclinical phase: proof of concept and safety profile

This stage marks the transition from fundamental research to human trials. Its objectives are to demonstrate proof of concept (efficacy) and assess the toxicity of the drug candidate. The partnership requirements here focus on cutting-edge scientific expertise: screening and selection of candidates, relevant animal models, and pharmacokinetic (ADME) and toxicology studies.

 

The clinical phase: methodological requirements and patient safety

From the start of phase I (first administration to humans) through to phase III, the challenges evolve. Beyond the scientific aspect, the priority extends to logistics, the protection of individuals and strict compliance with ethical and regulatory standards. This cycle does not end with the granting of authorisation: it continues with post-marketing pharmacovigilance.

Each of these phases requires specific skills and structures.

 

 

Identify key outsourcing stakeholders

The R&D services market is segmented. Distinguishing the roles of each partner is a prerequisite for building an effective project team.

 

CROs (Contract Research Organisations)

These are the central partners in outsourcing. A CRO can take on all or part of the operations.

• Preclinical CROs: these have the infrastructure and equipment necessary to conduct regulatory pharmacokinetic and toxicology tests.
• Clinical CROs: these orchestrate the operational implementation of trials: submission and obtaining approval for clinical trials, site selection, monitoring, data management and biostatistical analysis.

The choice between a global organisation (present in America, Europe and Asia) and a niche CRO (specialising in oncology or gene therapy, for example) will depend on the size of the trial and the resources allocated.

 

Specialised analytical laboratories

Some tests require specific expertise that generalist CROs do not always possess. This is the case for sample bioanalysis (pharmacokinetics/toxicology), the development of complex biomarkers, immunogenicity, and certain genomic analyses. These state-of-the-art laboratories are therefore essential for obtaining robust biological data.

 

Regulatory experts and consultants

Although they are not directly involved in experimental operations, their role is crucial. They anticipate the requirements of agencies (EMA, FDA) in order to prevent costly data from being rejected for non-compliance. A solid regulatory strategy then makes it possible to secure the process and reduce development time.

 

Patient associations and research centres

These stakeholders are essential, particularly in the field of rare diseases. Collaborating with an association at an early stage helps to optimise the protocol design to ensure its feasibility for patients and thus facilitate recruitment. Similarly, the selection of investigation centres (hospitals, networks such as Unicancer or research institutes) determines the speed of inclusion. In this regard, there are specific challenges, particularly for low-prevalence diseases.

Read our analyses on the development of medicines for rare diseases.

 

 

Selection criteria: prioritising long-term value

Selecting a service provider based solely on economic criteria represents a major risk. This can impact the viability of the marketing authorisation application. Here are the fundamental criteria to evaluate.

 

Technical expertise and therapeutic experience

Has the partner already conducted a similar trial? Do they have expertise in the specific biomarkers for your therapeutic area? A CRO with expertise in cardiology will not necessarily be effective for a vaccine or cell therapy.

 

Regulatory compliance: the distinction between GLP and GCP

Mastering this framework is crucial.

• In preclinical trials: it is important to note that not all studies require GLP (Good Laboratory Practice) certification. Exploratory discovery or early pharmacology studies may be conducted in a ‘non-GLP’ manner (with scientific rigour). However, pivotal safety studies (regulatory toxicology) must comply with GLP.
• In clinical trials: at this stage, compliance is mandatory. Compliance with GCP (Good Clinical Practice) is mandatory for all clinical research. To ensure the compliance of your future trials, it is essential to understand the requirements of the EMA (European Medicines Agency).

 

Communication and transparency

In a complex development project, unforeseen circumstances will inevitably arise. A reliable partner is one who immediately reports difficulties and proposes a corrective solution. Transparency regarding progress, deviations from protocol and budget management is a key indicator of trust.

Financial and operational stability

For a biotech company, ensuring the financial stability of its CRO throughout the entire Phase III trial is vital. Similarly, it is important to verify their IT capabilities and GDPR compliance (Health Data), issues that are increasingly monitored by the authorities.

 

 

The importance of centralised regulatory coordination

The multiplicity of stakeholders creates fragmentation that can hinder the project. This compartmentalised approach often leads to inconsistencies in the final dossier.

It is in this context that the support of a consulting firm with expertise in regulatory affairs guarantees overall consistency:

• Roadmap: support for establishing regulatory requirements and the type of studies to be conducted, consultation for scientific advice (when, how and where, depending on the stage of development, the type of molecule and the pathology).
• Strategic alignment: verifies that the protocols proposed by the CRO adequately address the scientific questions raised by the EMA or FDA.
• Smooth communication: liaises between the raw data from the laboratories and the drafting of the CTD (Common Technical Document)* modules.
• Compliance control: ensures that practices comply at all times with the requirements of agencies, in particular the EMA (Europe) and the FDA (US).
• Anticipation: prepares the final stages from the start of the trials.

* Standardised structure, agreed upon by international regulatory authorities, for the submission of marketing authorisation applications (MAAs).

To visualise the outcome of this work, understand the process for obtaining marketing authorisation (MA) for a new drug.

This coordination is also essential for preparing for the post-MA phase. The data collected during clinical trials form the basis of the future monitoring system. Inadequate management of safety data during the clinical phase will complicate the implementation of future obligations, particularly with regard to post-MA pharmacovigilance obligations.

 

 

Conclusion

The choice of partners for preclinical and clinical development requires in-depth analysis. The aim is to build a network of complementary skills capable of transforming scientific innovation into medical reality. Regulatory coordination therefore provides strategic direction for development. Without an integrated view of regulatory requirements, technical excellence alone does not guarantee market access. Alhena Consult positions itself at this critical interface to secure your choices and streamline the path of your innovation to patients.
Would you like to structure your development plan and secure your choice of service providers? Our experts are available to audit your strategy.