Clinical Consulting

Turn Clinical Complexity Into Competitive Advantage.

Clinical consulting is the backbone of getting regulated products to market. Whether you’re developing a medical device, pharmaceutical, combination product, or biologic, your clinical strategy can make or break your regulatory success. You need more than just a contract research organization (CRO) – you need experts who know how to facilitate smart studies, build airtight protocols, and deliver documentation that holds up under US FDA and EU scrutiny.

At QualityHub, we connect you with experienced clinical consultants who understand your product, your market, and the regulatory landscape you’re up against. From first-in-human studies to pivotal trials, from Clinical Evaluation Reports to submission-ready packages, we streamline every step with the right people and the right tools.

You don’t need to spend weeks hunting down vendors, writing RFPs, or managing spreadsheets. QualityHub matches you with vetted experts and proven partners fast, including clinical affairs pros, regulatory writers, biostatisticians, and CROs that know how to do it right.

If you’re launching a new product, updating for upcoming regulatory requirements, or stuck in clinical limbo, QualityHub gives you the clarity and power to move forward with confidence. Let us help you cut through the noise, avoid costly mistakes, and get to market smarter.

Ready to turn clinical complexity into clinical confidence? Learn more about our clinical consulting services listed below.

QualityHub knows that clinical strategy development is the linchpin of a successful clinical program. Our consultants begin by conducting a thorough assessment of your product’s intended use, target patient population, competitive landscape, and regulatory environment. They integrate insights from market analysis, scientific literature, and prior clinical experience to formulate a customized clinical development plan that balances scientific rigor with business goals.

This plan outlines the clinical pathways best suited to your product; for example, whether to pursue early feasibility studies, pivotal randomized controlled trials (RCTs), or real-world evidence (RWE) generation through registries and observational studies. QualityHub works with you to identify critical clinical questions, define precise clinical endpoints (primary and secondary), and determine success criteria that align with expectations for the US FDA and other regulatory bodies worldwide.

Strategic planning also incorporates risk-benefit analysis, budget optimization, and timelines to create an efficient, feasible roadmap. This ensures your clinical data package will be compelling to regulators, payers, and investors while minimizing development costs and timelines.

Designing a clinical trial that meets regulatory standards and scientific validity requires a meticulous attention to detail. That’s why QualityHub consultants develop comprehensive study protocols that include clear inclusion and exclusion criteria to select appropriate patient populations and avoid confounding variables. They determine whether the study will be randomized, controlled, blinded, or non-blinded based on the characteristics of a medical device, pharmaceutical or other regulated product.

The design phase includes defining the type of control group (placebo, active comparator, historical control), sample-size calculations grounded in statistical power analysis to detect meaningful differences, and the expected duration needed to observe clinically relevant outcomes.

Endpoints are chosen based on clinical relevance and regulatory guidance – they might include safety endpoints, efficacy measures, or patient-reported outcomes. QualityHub also builds in interim analyses and stopping rules where appropriate to effectively manage risks and resources.

In complex trials, adaptive designs or innovative methodologies such as Bayesian statistics or platform trials may be recommended to increase efficiency and flexibility. The final protocol undergoes rigorous review to ensure compliance with Good Clinical Practice (GCP) and alignment with regulatory expectations.

QualityHub can prepare and refine the clinical components of regulatory submissions. For the US FDA, this includes assembling Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE), 510(k)s, and Premarket Approval (PMA) dossiers. Further, QualityHub can handle your CE mark technical files with ease to satisfy European regulators.

We ensure that clinical data summaries, clinical evaluation reports, and risk-benefit analyses are clearly and accurately presented so they verify that clinical evidence meets standards and expectations for quality, relevance, and completeness.

Beyond documentation, QualityHub assists in managing interactions with regulators by preparing responses to questions, clarifying data interpretations, and participating in interactive review sessions. This helps manufacturers anticipate regulator concerns, reduce cycles of additional information requests, and expedite approvals.

They also help ensure alignment between clinical and non-clinical data, such as bench testing and preclinical studies, to provide a comprehensive safety and efficacy profile.

Once the clinical strategy and protocol are set, clinical operations management ensures flawless execution of the trial. QualityHub consultants assist in selecting clinical sites with the proper patient populations, experienced study investigators, and the infrastructure to conduct quality research.

We also manage site initiation visits, train clinical staff on protocol adherence, and establish monitoring plans tailored to study risk profiles. Further, patient recruitment strategies are developed to meet enrollment targets on time, including outreach, patient engagement, and retention programs.

Operational oversight includes site monitoring visits to verify data accuracy and adherence to regulatory requirements, management of protocol deviations, and ensuring compliance with ethical standards approvals by a US Institutional Review Board (IRB) or internationally by an Independent Ethics Committee (IEC).

QualityHub coordinates communications between contract research organizations (CROs), clinical sites, sponsors, and regulatory bodies to maintain transparency and the quick resolution of issues. We also manage budgeting and timelines, proactively addressing risks and bottlenecks to keep trials on track and within budget.

Robust data management and statistical analysis underpin the credibility of clinical trial results, so QualityHub designs case report forms (CRFs) and electronic data capture (EDC) systems that are optimized for accuracy and efficiency.

We oversee data collection workflows, implement data validation checks, and handle data cleaning to address inconsistencies, missing values, or outliers. Also a top priority is ensuring that data integrity includes adherence to regulatory requirements like 21 CFR, Part 11 in the US for the use of electronic records and electronic signatures, and the EU’s General Data Protection Regulation (GDPR) for patient data privacy.

QualityHub conducts prespecified and exploratory analyses to evaluate safety and efficacy endpoints, using appropriate statistical methods such as survival analysis, regression models, or subgroup analyses. Our experts prepare detailed statistical analysis plans (SAPs) before database lock, and post-analysis, generate clinical study reports (CSRs) that clearly present results with transparency and scientific rigor.

After regulatory approval, maintaining product safety and effectiveness requires ongoing clinical vigilance. QualityHub can design post-market clinical follow-up (PMCF) studies or registries that systematically collect data on medical device or pharmaceutical performance in real-world settings.

We also develop risk management plans that include adverse event detection, reporting, and mitigation strategies, while continuous data monitoring enables early identification of emerging safety issues or changes in effectiveness, allowing for timely corrective actions.

QualityHub also makes sure your company is compliant with evolving regulatory requirements for post-market surveillance, such as the US FDA’s post-approval study mandates or the Medical Device Regulation (MDR) in the EU. Our long-term clinical oversight supports product lifecycle management, informs product improvements, and builds trust with clinicians and patients.

Because successful clinical programs depend on consistent, high-quality execution by clinical investigators and staff, QualityHub develops tailored training materials and programs to ensure comprehensive understanding of study protocols, product use, safety reporting, and compliance requirements.

Training may include in-person workshops, webinars, or e-learning modules, and is often customized by role, from site coordinators to principal investigators.

Ongoing education supports adherence to Good Clinical Practice (GCP), reduces protocol deviations, and fosters a culture of quality and safety. It also enhances data reliability and ultimately strengthens the credibility of your clinical evidence.

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