FEATURED CONTENT

• How Can Sponsors And CROs Execute SDTM Faster With Lower Costs?

  How can sponsors ensure SDTM compliance while still maintaining the efficiency and speed necessary to meet their trial timelines and milestones? Find out here.

• Trusted Long-Term Partners That Sponsors Can Depend On

  Bioforum and Medidata have been working together for nearly a decade, with approximately 30 joint projects to date – half of which are ongoing. Find out more about their collaboration in this brochure.

• Important Mistakes To Avoid Before Submitting A Molecular Biology Manuscript

  In this blog post, read about the technical problems that might arise when writing molecular biology articles if not properly proofread.

• Risk Based Approach In Data Management

  Data quality within the clinical research enterprise can be defined as the absence of errors that matter and assurance that the data is good enough to fit the purpose. Discover how this can be measured in this blog.

• AI In Data Management

  In this blog, learn why the machine learning approach means that a more focused review of data is driven by “lessons learnt” from previous trial data.

• Using Risk-Based Monitoring To Focus On Timelines, Quality, And Budget

  Tanya du Plessis, VP of Data Solutions and Strategies at Bioforum, and Rich Davies, VP of Solutions Expert at CluePoints, explain the principle applications of RBQM to Data Management.

• The ROI Of Risk Based Data Management

  Increased industry costs are driving reflection towards current practices in order to determine where efforts can be decreased in order to save costs. Learn how risk based monitoring has drastically reduced the cost of clinical monitoring.

• A Guide To The Multifaceted Role Biostatisticians Play In Clinical Research

  Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the collaborative effort to develop new drugs and devices. But what exactly do biostatisticians do?

• Writing A Clinical Study Protocol As A Regulatory Document

  Discover why a clinical study protocol needs to be presented using clear and unambiguous essential rules to facilitate the compliance of all study stakeholders.

• A Brief Overview Of The Quality Checking Process

  Research documents must be inspected for accuracy and integrity. The careful eyes of a Quality Checking (QC) expert are required to notice and correct errors that might otherwise render all the writer’s and researchers’ work unpublishable.

• Preparing A New Drug Application (NDA) With A CDISC Conversion

  Regulatory submissions are the most critical milestones in clinical research programs. Learn how quality submissions can accelerate time to market, maximize research investments and bring the benefit of new treatments to patients sooner.

• Six Best Practices To Factor Into Effective Data Migration Planning

  Although it may feel daunting, explore how a study migration can be successfully managed with a solid, well thought-out data migration plan.

• Regulatory Approval For Novel Device Achieved With Comprehensive Clinical Data Management

  Find out how data capture and management activities, programming, and medical writing for a clinical study report were supported to solve the major diagnostic challenge of distinguishing between bacterial and viral infections.

• Five Things To Remember When Selecting A CRO Partner

  In September 2021, the FDA issued a notification to the biopharmaceutical industry alerting them that multiple clinical studies conducted by two India-based CROs were “not acceptable” because of data integrity concerns. How can sponsors avoid such situations when selecting and partnering with CROs?