Strategic Consulting

Advanced clinical research consulting for efficient product development, from dose-finding to confirmatory trials

In today’s complex clinical research landscape, integrating advanced statistical methods with a deep understanding of regulatory requirements has never been more crucial. Our mission is to ensure the success of your clinical trials, guiding you effortlessly towards regulatory approval.

At Almustat, we combine decades of experience with unmatched expertise in biostatistics, regulatory strategies, and approval-optimizing approaches to help you confidently navigate the intricacies of clinical development.

Is Your Clinical Development Strategy READY for Success? Let us be your partner on the path to excellence.

LET'S CONNECT

Advanced clinical research consulting for efficient product development, from dose-finding to confirmatory trials

Almustat is your steadfast partner, providing regulatory statistics and approval-optimizing strategies to serve as your roadmap to success in clinical development.

Approval-Optimizing Strategies: Your Blueprint for Success

Streamlined Clinical Development Plans: Leveraging our expertise in regulatory-driven statistical knowledge and innovative methodologies, Almustat not only supports strategic decision-making but also optimizes your clinical development journey. Our streamlined approach helps you reduce time to market, confidently moving towards approval.

Enhanced Data Quality Assurance: With our in-depth understanding of regulatory guidance, we ensure unmatched data quality, enhancing the credibility of your trials and maximizing the chances of regulatory approval.

Regulatory Statistics: The Foundation of Your Trial’s Success

The Backbone of Trial Design: Regulatory statistics are fundamental to the design of trials involving drugs, biomarkers, and medical devices. At Almustat, we deliver methodologically robust trial designs that not only fulfill stringent regulatory requirements for safety and efficacy but also boost the credibility of the data submitted for regulatory approval.

Expert Consultation for Optimal Outcomes: Our skilled consultants excel in determining the ideal sample size, selecting the most suitable endpoints, and implementing effective randomization techniques to create a solid foundation for your trial—maximizing the likelihood of gaining regulatory approval for your drug or device.

Comprehensive Services for Optimized Clinical Development Strategy

Almustat’s suite of strategic consulting services—spanning clinical study design, protocol development, and regulatory submissions, including FDA/EMA meeting representation—is crafted to elevate your clinical development strategy with unmatched expertise and insight.

Trial Design Services

Adjusted Level of Complexity: We offer a broad range of trial designs, including conventional, group-sequential, adaptive, biomarker-based, and other complex and innovative approaches.
Appropriate Statistical Framework: Expertise in both Frequentist and Bayesian statistical designs to suit your trial’s unique requirements.
Optimized Interim Decisions: Including stopping rules, group-sequential designs, and sample-size re-estimation to ensure efficient decision-making during the trial.
Bias-Mitigating Methods: Implementing effective randomization procedures and utilizing real-world data (RWD) and real-world evidence (RWE) to minimize bias.
Sample-Size Calculation and Simulations: Accurately calculating sample sizes and conducting simulations to enhance trial planning and execution.
Input on Study Features: Providing input on population selection, endpoints, and outcome assessments to ensure comprehensive study planning.
PK/PD Analysis: Specializing in non-compartmental analysis (NCA), population pharmacokinetics (PK), and modeling for a deeper understanding of pharmacokinetic and pharmacodynamic properties.

Our trial design services are crafted to ensure rigorous, scientifically sound studies that are adaptable to regulatory and practical requirements.

Clinical Input for Development Plans
Building on available preclinical and clinical data, Almustat supports you in making strategic decisions essential for advancing clinical drug development and securing product approval.

Regulatory Support
Our regulatory guidance covers IND and NDA submissions, pediatric exclusivity, rare disease/orphan drug designation, as well as IVD and medical device clearances and approvals. We provide the expertise needed to confidently navigate the path to regulatory approval.

Input in Licensing Deals and Portfolio Management
Expert insights to support licensing deals and manage your product portfolio effectively, ensuring strategic growth.

Advanced Biostatistics

Validation of Surrogate Endpoints: Providing robust statistical validation for surrogate endpoints to accelerate decision-making.
Seamless and Efficient Early Phase Designs: Crafting optimized designs for early-phase trials to expedite clinical development.
Generalized Pairwise Comparisons (GPC): Implementing GPC to enhance trial analysis, allowing for patient- and clinician-centered decision-making.

Our comprehensive support is designed to streamline development, optimize strategies, and help you achieve successful outcomes in clinical trials.

Advanced clinical research consulting for efficient product development, from dose-finding to confirmatory trials

Advanced clinical research consulting for efficient product development, from dose-finding to confirmatory trials

Comprehensive Services for Optimized Clinical Development Strategy

Partner with Almustat for Confidence

Comprehensive Services for Optimized Clinical Development Strategy

Learn more on our Flexible and Innovative Approach to Clinical Study Design

Quick Links

Visit Us

Call

Make an Appointment