Study Startup Leader or Laggard? Time to Access Your Level of Maturity
Self-Assessment Helps Stakeholders Reflect on Study Startup Status
Quality management and competitive edge are vital to the clinical trials sector, and are fueling widespread use of purpose-built technology. Cloud-based solutions, such as clinical trial management systems (CTMS) and electronic trial master file (eTMF), are broadly accepted, but these tools fail to address study startup (SSU), a complex set of processes that contribute heavily to lengthy timelines, often lasting seven years. With greater globalization of clinical trials and factors ranging from site selection to regulatory document submission to enrolling the first patient, assessing SSU status is critical. It pinpoints bottlenecks and areas of risk that could impact data quality and derail study budgets and timelines.
Risk is playing a more visible role, given the growing emphasis on risk-based management by regulators and industry's steady push for speeding therapies to patients, suggesting that it is time for stakeholders to determine if they are SSU leaders or laggards.
Download our white paper "Study Startup Leader or Laggard? Time to Access Your Level of Maturity" to learn about why this assessment is timely and how this assessment is critical to those organizations engaged in starting clinical trials.
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