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Early-Phase Clinical Expertise in Proof-Of-Concept Studies

Whether you are expanding a first-in-human (FIH) study with patient cohorts or conducting a standalone POC study, our role is to help you detect early signals of clinical efficacy through the right biomarkers, endpoints, and patient populations. Our integrated early-phase expertise ensures your POC study generates the actionable insight needed to support go/no-go decisions and Phase II/III strategy.

Early-Phase Clinical Expertise in Proof-Of-Concept Studies

Altasciences is the premier organization for early-phase clinical research with extensive expertise in conducting POC studies. We have designed, managed, conducted, analyzed, and reported on hundreds of POC studies, with varying degrees of complexity.

First-in-Human Studies

We focus on early-phase development, so your FIH trial will never compete for resources with larger, later-phase trials. We have the know-how to design and implement adaptive complex protocols, incorporating patients, early POC measures and efficacy endpoints, biomarkers, pharmacodynamic assessments, and more. With our centralized program and project management, we help you achieve critical Phase I milestones efficiently to maximize your investment.

Standalone Proof-of-Concept Studies

With Altasciences, your POC study can be designed once initial efficacy-relevant data emerges. Our approach focuses on selecting the right biomarkers, clinical endpoints, and patient cohorts to evaluate early therapeutic activity. Operational readiness—including parallel feasibility, early site engagement, and adaptive designs—supports faster access to the data you need, but the goal remains early insight into efficacy to inform Phase Ib/IIa progression.

Our tailor-made, fully integrated solutions, adaptive protocol designs, and focused clinical study management ensure we’re ready to support your next steps, in Phase Ib and IIa clinical trials.

Integrated Clinical Solutions for Phase Ib/IIa Studies

We offer a comprehensive solution to site selection and the flexibility to conduct your study entirely through our clinical site network, solely within our clinical research units, or through a hybrid model utilizing both. Through expert feasibility and site identification, we assess each site's capabilities based on therapeutic alignment and patient access, geographic and regulatory considerations, and historical enrollment performance to ensure the right fit for your protocol. Combining our three North American clinics with a global network of 300+ active partner sites, we have the infrastructure to meet your specific needs to access a variety of specialized patient populations and therapeutic areas.

Accelerated Proof-Of-Concept Clinical Trial Start-up

We know that speed matters in early development, because it accelerates access to early clinical data. That’s why we have developed a comprehensive and streamlined approach to our start-up process that is proactive while reducing common risks to support both a single site execution and complex multi-center strategy. Our dedicated Project Manager coordinates all aspects of planning and activation, ensuring seamless communication and consistency across all clinical locations, cross-functional areas, and vendors. Because we operate as a unified team, our Altasciences integrated Clinical Research Support Services are built for speed, agility, accuracy, and consistency to help you begin collecting early efficacy-relevant data sooner—supporting informed continuation, modification, or termination or your program.

Our proven FIH hybrid model employs a two-pronged strategy to mobilize initiation of early healthy volunteer cohorts at one of our Altasciences clinics in parallel, while expanding patient populations at one of our external partner sites —without delay. If your trial is best suited for our clinical site network, Altasciences expertly leverages our vetted sites. With our long-standing site relationships, we have pre-established Master Services Agreements (MSAs) and budget templates, allowing us to significantly reduce start-up timelines by eliminating common bottlenecks.

Knowing the operational aspects of our partners, which are tracked in our proprietary Ask Albert proprietary database, and continued engagement and discussions on growing capabilities, Altasciences Site Solutions has a streamlined feasibility and operational planning process with our external partner sites, allowing for accelerated initiation without sacrificing quality or compliance. This level of readiness ensures sponsors can evaluate early signs of therapeutic activity as soon as possible which is foundational to POC decision-making.

Proof-Of-Concept Clinical Study Enrollment Strategies

We tailor our enrollment strategies to match your study’s needs, leveraging the strengths of both our internal clinics and our external site network to ensure the appropriate patient populations are recruited to evaluate early clinical efficacy and biomarker responses.

At Altasciences’ clinics, we routinely perform POC clinical research in healthy participants and also leverage our access to a wide range of specialty patient populations for indications that cannot be administered in healthy participants.

Study Participant Populations

• Healthy Participants
• Special Populations
• Patient Populations

Prior to study start, our recruiting department produces an accurate estimate of enrollment projections and timelines verifying that the availability and characteristics of the population support meaningful POC signal detection. For some indications, we can recruit a large number of patients (i.e., diabetes, obesity, and osteoarthritis), while in others, we conduct POC research with smaller cohorts and may involve external sites.

For studies requiring patient populations not readily available in-house, or those needing geographic diversity, we engage our clinical site network. Each partnership is supported by a structured enrollment strategy and proactive risk management framework to ensure success.

• Pre-award feasibility, which leverages existing relationships with partnered sites, provides reliable site screening, enrollment and patient data allowing accurate early modeling and protocol design feedback.
• Post-award feasibility focuses on selecting the best, fit for purpose sites evaluating population access, historical performance, and competing studies.
• Project and site-specific enrollment plans are developed that align with protocol requirements and local patient availability.
• Risk identification tools are used to flag potential enrollment barriers early (e.g., seasonal factors, eligibility constraints, or regulatory delays)
• Ongoing communication with site staff allows for effective patient enrollment and retention monitoring with contingency planning for underperforming sites, including access to backup sites through our broader network.

Turnkey Solution for Proof-Of-Concept Trials

At Altasciences, we offer a turnkey solution for conducting POC studies, handling every aspect of your trial from start to finish. Our comprehensive services include:

Study Design:

Our clinical pharmacologists perform background research, and consult with research specialists, to ensure we craft the ideal, customized design to meet your POC objectives, including collaborating with our preclinical colleagues to select the models or biomarkers, endpoints, and translational measures needed to evaluate early efficacy.

Protocol Review and Development:

Protocol deviations can pose serious threats to the overall success of a clinical trial, which is why we are committed to mitigating these risks before they occur. Through detailed protocol analysis and top-level insight, our risk management planning identifies, evaluates, controls, communicates, reviews, and reports risks.

Clinical Conduct:

Our three state-of-the-art clinics across North America are fully equipped to run your POC study, with expert teams managing dosing, sampling, and intensive monitoring. We have dedicated USP 797 pharmacies on site and, from QT assessment to pain scales, cognitive evaluations to MRI scans, we can deliver the specialized procedures your study requires.

Comprehensive Clinical Monitoring:

Our CRAs are conveniently located in close proximity to our clinics across North America and offer clinical trial expertise and experience in multiple therapeutic indications.

Real-time tracking of pharmacokinetics (PK) and pharmacodynamics (PD) data, safety assessments, and adverse event reporting, ensures compliance with regulatory requirements and maintaining data integrity throughout the POC trial.

• Remote and Decentralized Monitoring:
  Using remote monitoring platforms to support virtual visits and real-time communication, we improve monitoring efficiency as well as patient experience and retention. Further increasing efficiency, decentralized monitoring leveraging mobile apps and wearable devices to collect real-time patient data remotely, can reduce the need for site visits while also expanding access to diverse populations./li>
• Risk Based Monitoring (RBM):
  Leveraging centralized analytics to identify and prioritize high-risk sites, evaluations, and datapoints, allows us to efficiently allocate our CRA resources to conduct targeted oversight. We ensure continuous risk assessment throughout the trial, focusing monitoring efforts where they are most needed.

Bioanalytical Services:

Our state-of-the-art, co-located bioanalytical labs are equipped with over 685 validated methods for a wide range of POC studies, ensuring precise and timely data delivery. Leveraging these established methods, we provide the reliable data you need to meet regulatory standards, informing and enabling faster decision-making. We support clinical trials worldwide with accurate, efficient, and safe preparation, collection, and shipment of clinical samples. Our customized collection kits and manuals are designed to facilitate the handling of your samples at every step of your study.

Data Services and Reporting:

We handle data management, analysis, and comprehensive reporting to deliver high-quality results on time. Our data management and reporting services are designed to deliver accuracy, speed, and regulatory confidence from study start to submission. With integrated teams, industry-leading technology, and a relentless focus on data quality and security, we help you make informed decisions faster while ensuring full compliance and transparency every step of the way. Experience real-time data access, customizable reporting, and expert guidance that put your trial - and your patients - first.

Regulatory Consulting:

Need support navigating regulatory requirements? We begin with the end in mind and can engage with you as early as possible to map out your complete development plan. From preclinical testing through FIH, POC, and clinical pharmacology testing, our experts can assist with mapping out what will be required to satisfy guidelines across regulatory agencies and when you should conduct each phase, including the critical POC trial. We begin with the end in mind and can engage with you as early as possible to map out your complete development plan.

At Altasciences, we’re fully equipped to conduct your POC study, deliver it on time, and ensure it is fully enrolled with the right participants.