CRO support for personalized medicine

Contract Research Organizations (CROs) are playing an increasingly important role in supporting the pharma industry’s growing embrace of Personalized Medicine, treatments tailored to individual genetic and patient profiles.

This requires innovative approaches to drug formulation and delivery; areas where CROs such as Delim can make a real difference with their specialized capabilities in creating semi-solid and solid oral formulations with specific release profiles for customized treatments.

Personalized Medicine paradigm shift

Personalized medicine is being driven by a convergence of scientific, technological, clinical, and patient-centric factors.

Principal drivers include advances in Genomics and Molecular Biology that have engendered deeper understanding of how genetic variation influences disease and drug response, laying the ground for more precisely targeted therapies.

This shift also reflects growing unease that traditional “one-size-fits-all” treatments can lead to variable outcomes or adverse effects, with the imperative to reduce risk and improve patient safety by tailoring therapies more precisely to individual biology, lifestyle and environment.

A third factor is the new availability of Companion Diagnostics that can identify patients likely to benefit from specific therapies or those at risk of side effects, enabling smarter treatment selection. This is part of a wider picture of Technological Innovation in drug development and delivery, with advances such as wearable biosensors, 3D printing of medications, AI-driven drug discovery, and biologics all providing new ways to deliver individualized dosage forms. These responses match growing consumer expectations of customized healthcare solutions that recognise patients as individuals.

Perhaps the single most powerful factor is Data-Driven Medicine; the use of big data, electronic health records, and real-world evidence to allow researchers and clinicians to stratify patients and predict responses more accurately. Artificial intelligence (AI) and machine learning further enable analysis of complex datasets to support personalization.

Together, these factors are driving a global shift toward more effective, safe, and individualized healthcare that regulatory agencies like the FDA and EMA have recognized by developing frameworks and incentives to support the development of personalized therapies and companion diagnostics.

Personalised cosmetics

The personalization trend is also strongly evident in the cosmetics and skincare industry, driven by similar consumer expectations and technological advances. Here, it is exhibited in various ways, most of them direct parallels with pharma and healthcare.

So, for example, the Skin Diagnostics and Assessment Tools that brands now offer via AI-powered skin analysis apps, in-store facial scanners, or online quizzes to assess a customer’s skin type, concerns, and environment are diagnostics to shape personalized product regimens, mimicking companion diagnostics in drug therapy.

The Custom-Formulated Products blended from individual skin data, such as oiliness, sensitivity, or pigmentation, with ingredients and concentrations tailored to consumer genetics, climate, age, and skin goals also emphasize the rethinking of the ‘one size fits all’ model.  At the same time, DNA and Microbiome-Based Formulations again mirror the similar genomics-driven approach in medicine.

A further example is On-Demand and Modular Beauty, where consumers can mix and match serum boosters, base creams, or active ingredients at home, creating modular skincare tailored to fluctuating daily needs – a parallel with the flexible, patient-specific dosing strategies seen in personalized drug delivery.

Cosmetics is also embracing Real-Time Personalization via Smart Devices using smart mirrors, wearable sensors, or apps to provide real-time feedback on skin condition and recommend product adjustments — akin to digital therapeutics in personalized health.

Cosmetics companies, too, are leveraging big data, machine learning, and consumer feedback to continuously refine product formulations for individuals to produce Data-Driven Product Recommendations.

The Evolving Role of CROs

The traditional CRO functions, such as preclinical studies, clinical trials, and bioanalytics, have expanded to take on new roles of formulation innovation and delivery optimization.

Pharmaceutical companies are increasingly turning to specialized Contract Research Organizations (CROs) for patient-specific formulations and delivery systems to meet the personalized medicine agenda.  Increasingly, they turn to CROs with niche expertise to develop more flexible drug delivery systems, such as modified-release tablets, topical gels, or pediatric-specific forms — to suit specific patient populations.

In part this reflects the complexity of modern drug delivery, with more targeted therapeutics often requiring innovative delivery platforms to optimize bioavailability, stability, or release profiles. Specialized CROs can bring to bear cutting-edge formulation technology, such as nanoemulsions or multiparticulate systems, using expertise that many pharma companies do not possess in-house.

Furthermore, personalized therapies that cater for niche patient groups, such as rare conditions or circumstances, require the speed and agility needed for compressed development cycles, including small-batch manufacturing, rapid prototyping, and scale-up — crucial for early-stage innovation and adaptive clinical trials.

At the regulatory level, CROs specializing in formulation science understand how to design compliant studies and documentation for complex delivery systems and personalized therapies.

Where personalized treatments are tied to biomarker-driven diagnostics, it is highly advantageous to use a CRO’s integrated services, from formulation to bioanalysis and PK/PD profiling, to ensure a more cohesive development workflow.

A key factor here is overall pressure for maximum cost efficiency and resource optimization, with outsourcing to specialized CROs giving pharma companies ‘on demand’ access specialized capabilities and expert talent, avoid building costly infrastructure, and reduce risk and time-to-market for novel or low-volume therapies.

Delim Personalized Formulation Development

Delim s.r.o. possesses a robust set of in-house capabilities that directly support pharmaceutical and biotech companies developing patient-specific formulations and innovative drug delivery systems. These include:

• Expertise in Customized Drug Formulation: For semi-solid dosage forms, Delim is highly experienced in developing personalized gels, creams, ointments, and transdermal systems tailored for topical or systemic absorption—ideal for dermatological, pediatric, or localized treatments. It is also expert in developing smarter OSD modified-release tablets, mini-tablets, and capsules, including patient-specific release profiles for enhanced therapeutic precision. Delim can also produce the low-dose and high-potency drug formulations that are essential for individualized medicine.
• Controlled Release & Targeted Delivery: Delim uses polymer and matrix technologies to design and test controlled release profiles to achieve site-specific or time-dependent drug delivery, critical for aligning with individual PK/PD requirements. This allows formulas to be tailored to age-specific needs, such as taste-masked and easy-to-administer forms.
• In-House Analytical & Stability Capabilities: Delim’s fully equipped analytical labs can carry out all the studies needed for personalized drug dosage or cosmetic formulations, including dissolution testing, content uniformity, stability studies to ICH guidelines, physical and chemical compatibility testing. These are essential to ensure formulation reliability and regulatory compliance.
• Pilot-Scale Manufacturing & Small Batch Production: Delim supports early-stage development with pilot-scale and small-batch GMP-compliant manufacturing, to meet such needs as clinical trial material supply, niche therapies, or low-volume, high-value personalized products.
• Agile Development & Regulatory Support: Delim likes to work in close collaboration with clients to rapidly prototype and adapt formulations, with its flexible team structures and short decision chains enabling quick turnaround and tailored project execution. It can provide the regulatory documentation required for CTA clinical trial applications and marketing submissions.
• Integration with Drug Development Workflows: Delim complements its formulation services with preclinical testing, compatibility studies, and support for bioavailability enhancement — ensuring seamless integration into the broader drug development pipeline.

Delim also has distinctive ability to create formulations that stand out for their novelty and patentability. Its dedication to innovation is demonstrated by the number and quality of patents it has successfully filed that have received approval. Noteworthy achievements include Udonitrectag and its topical formulations for treating dermatological conditions, pharmaceutical or cosmetic compositions with polymers and absorption enhancers for controlled API release, and thermosensitive mucoadhesive gel solutions based on collagen and hyaluronic acid salts for reversible applications. Delim is also a pioneer in the technology of loading tissues or garments with compositions for controlled active ingredient release.

By combining formulation innovation, analytical strength, and manufacturing flexibility, Delim provides pharma and cosmetic brands with an ideal CRO Partner for the Personalized Era. It is an essential enabler of the personalized medicine and cosmetics revolution by encouraging pharma, biotech, and cosmetics companies to leverage its specialized formulation expertise for rapid development and faster time to market for highly specific and tailored formulations.

Resources

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