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Get the latest updates, insights and best practices on data management and biostatistics in clinical trials.

AI for Decision Making: what does AI have to say about this?

Artificial Intelligence (AI) has already been used in many areas of clinical development and clinical trial design such as patient recruitment and matching, trial design and protocol optimization, site selection and feasibility, and monitoring and risk-based management. In this blog I am focusing on the potential role of AI in decision-making. To accomplish this, I …

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The Data Tsunami: How Clinical Trial Complexity Fuels Warning Letters

Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President  Data integrity in clinical trials refers to the completeness, accuracy, and reliability of trial data throughout its lifecycle. If  you read our previous blog “Regulatory Approval Top Red Flag: The Rise of Data Integrity Warning Letters” , you know data integrity is now the #1 reason …

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Defining success for early-stage, small biotech trials

Small biotech companies encounter significant challenges in designing and implementing clinical development programmes. These companies have an even lower rate of success than that of large, established companies, due to limited internal experience in clinical development and limited infrastructure.1 An even greater challenge is their need for external investment. During the early stages of development, …

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Case Study: Fast-Tracking Pi-Cardia’s FDA Submission with Data-Driven Expertise

Accelerating Innovation in Structural Heart Care: Bioforum’s Role in Pi-Cardia’s FDA Journey Bioforum is proud to have supported Pi-Cardia in securing FDA clearance for ShortCut™—a first-of-its-kind solution in structural heart care. This collaboration demonstrates the value of expert data management and regulatory strategy in accelerating life-saving medical innovations. ShortCut™: Transforming Valve-in-Valve ProceduresPi-Cardia’s ShortCut™ is the …

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Truths About Sample Size and How to Calculate It

Sample size is a quantity of immense strategic and ethical importance in treatment development. It is therefore surprising how many misconceptions there are among clinicians and statisticians regarding this topic. There are two parameters directly related to calculation of sample size: power and treatment effect. Let us first define the power of the trial. Power …

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The Evolution of Site Management Organizations: From Patient Access to Comprehensive Site Research Organizations

Introduction With over 50%[1] of drugs in development reflecting rare/orphan and oncology indications alone, the complexity amongst patient cohorts is real with the patient identification-recruitment-enrolment bottleneck becoming the single greatest critical factor (as if it wasn’t already) in the success of any clinical program. It is little wonder we are witnessing the proliferation of patient …

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Focusing Too Many R&D Resources on One Drug: The Hidden Costs of Clinical Trial-Level Decision-Making

Drug development is a high-stakes, high-cost endeavor. Every new drug entering clinical trials requires careful decision-making, particularly regarding trial design and resource allocation. However, when biopharmaceutical companies invest excessive resources into a single drug, they risk sidelining other potentially life-saving treatments. This short-sighted approach can result in missed opportunities for patients and significant financial loss …

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Value of strategic statistical consultants

Value of strategic statistical consultants Many sponsors are restricting the utilization of strategic statistical consultants to sample size calculations. By doing so, they are limiting the value they receive. Statisticians are best positioned to build a bigger picture in their minds and assess larger impacts of decisions made at various stages of development on ultimate …

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LEVERAGING MACHINELEARNING FOR SDTM MAPPING

Data standards support the robust organization, analysis, and reporting of clinical trials and many regulatory authorities mandate the use of standardized data structures for clinical trial submissions. The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) is a framework used to represent trial data in a standardized format for review. The SDTM …

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Case Studies: FSPs in Action

If you’re contemplating a Functional Service Provision (FSP) model to enhance your biometric team, understanding successful implementations can offer valuable insights. Here are three in-depth case studies showcasing the versatility and effectiveness of the FSP approach in addressing various needs in biometrics:   Case Study 1: Pharmaceutical Company – Fractional Data Management FSP Business Need: …

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