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. Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

    This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.

  7. The 3 Pillars Of A Life Science Quality Management System

    As life science companies progress through clinical development towards regulatory submission, if a quality management and process is not laid out from the beginning they face significant risks.

  8. Leveraging Time-Tested Assets For A Shift In Site Contracting & Patient Enrollment

    The unfailing ability to complete enrollment on time, every time, has been the greatest yet most elusive need among clinical trial managers. While the value of the external patient is becoming more apparent, finding optimum solutions for integrating them into a study’s enrollment strategy is not so obvious. In their struggle to find answers, clinical trial managers experiment with, and try to piece together, services and offerings from a wide and disparate range of sources. The results are as varied as the choices. Now, a new approach to patient enrollment is emerging – one that could change the world of clinical trials.

  9. The 3 Cs You Should Expect From Your Pharma Service Provider

    When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

  10. Is it Time To Upgrade To Electronic Drug Accountability?

    It’s no secret that the adoption of new technologies in support of clinical trials moves at a pace considerably slower than other industries. Disruptive technologies in other sectors can change business models almost overnight.