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 …
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 …
Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President Introduction Clinical data standards have been around for almost 20 years. Regulations for preparing clinical data submissions have been mandatory for nearly a decade. Yet, as will be shown below, FDA rejections and data-related warning letters continue to rise. This blog kicks off a series focused …
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, …
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 …
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 …
As medical writers, staying ahead of regulatory changes is crucial. The shift from ICH E6 R2 to ICH E6 R3 brings several updates that we need to be aware of to ensure our documentation remains compliant and effective. Here’s a breakdown of the key differences and their impact on our work. Embracing Risk-Based Approaches ICH …
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 …
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 …
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 …
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 …
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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