White Papers

  1. Clinical Study Leader Or Laggard?

    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 the 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.

  2. Deep Knowledge Of Clinical Study Startup Points Data In Right Direction

    Purpose-built SSU solutions track clinical trial operations using much needed standardized performance metrics.

  3. Modern Risk Management In Global Pharmaceutical Logistics

    Everything pharmaceutical manufacturers want to know about risk in supply chain logistics but are afraid to ask. What are the rising trends impacting security of product in transport? When and where does risk mitigation become mission critical? And — perhaps the most burdensome — how can I be sure?

  4. How Sponsors And CROs Benefit From EDC Efficiencies

    The question used to be a relatively simple one: how can a pharmaceutical company conduct efficient and effective trials? As the industry has changed over the past decade, pharmaceutical companies need the ability to access study information in real time so they can make better decisions regarding the viability of a compound as soon as possible in the study process. In no uncertain terms, time equals money in this industry.

  5. Effective EDC Should Be Accessible And Affordable For All Clinical Trials

    The number of clinical trials conducted per year, their complexity, and the percentage of trials experiencing delays have all been increasing in recent years, accompanied by spiraling costs and lengthening trial times. This trend, along with a rise in overall drug development costs, has been occurring at a time when governments, payers, and patients are demanding that pharmaceutical manufacturers provide evidence of measurable value for any new treatment.

  6. The Competitive Advantages Of Accelerating Payments To Investigative Sites

    A successful clinical trial is a collaboration between the sponsor, the investigative sites, and the patients, each of whom plays a unique and indispensable role in the clinical development process.

  7. Sensible Trial Management: Putting Contract Terms To Work To Save Money And Improve Trial Performance

    In today’s competitive clinical trial landscape, success is synonymous with monitoring site performance. At the helm of any successful trial is the sponsor.

  8. Clinical Trial Expense Accruals: Easing The Challenge And Audit Risk

    From the outset, the process of generating expense accruals for clinical trials has been a challenging accounting task for life science companies.

  9. ROI Initiative: A Technology Solution For Investigator Payments

    Managing investigator payments faces specific, well-known challenges. Current systems are fragmented and manual, and in most cases are not transactional or financial-based.

  10. CRO Governance And Collaboration In Clinical Trials Using CTMS

    Activities once performed internally, such as trial design, data management, monitoring, site management, payments and clinical review oversight, today are outsourced to CROs and external providers from a wide geographic region. By  Lynn Fraser, Product Manager & Development, Bioclinica; Jeremiah Rehm, Clinical Solutions Specialist, Bioclinica