Insights On Partnering

  1. CRO Selection Taken Seriously 11/25/2019

    Industry Standard Research (ISR) asked over 500 clinical-development outsourcers their level of agreement with the statement: My organization’s mix of CROs is not likely to change much in the next two years.

  2. Simplifying CRA Reconciliation: 5 Ways To Improve Site Visits 6/24/2019

    CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how  with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.

  3. 4 Ways To Avoid Failure In Phase III Clinical Manufacturing 9/19/2018

    Understanding the challenges in the biopharma space is critical, as the planning you do today dictates the options you have later when the costs — and the stakes — get even higher.

  4. Protecting The Integrity Of Your Temperature Data In A Digital World 2/26/2019

    Watch Almac’s on-demand webinar to gain an understanding of data integrity regulations and key considerations when utilizing a computerized system to manage temperature data during clinical trials.  This webinar will demonstrate how a secure, validated system is key in ensuring effective collection and management of accurate temperature data from the entire clinical supply chain.  

  5. How Are Adaptive Trial Designs Improving Efficiency In Clinical Research? 4/29/2019

    The ability to adapt is a valued attribute in today’s constantly changing world, and clinical trial designs are no exception. Adaptive trial designs can save sponsors significant time and money, but they need to be approached with caution and planning.

  6. Phase 3 Bacterial Vaginosis Study 8/28/2019

    Ensuring that studies meet the business goals of sponsors and increase the range of treatment options available to patients and healthcare providers can be challenging when a trial must enroll subjects with a bothersome health condition and ask them to risk randomization to placebo. The project team in a study of an investigational treatment for bacterial vaginosis addressed such challenges and enabled the study to meet the sponsor’s goals.

  7. Capabilities For Clinical Studies In Contraception 8/28/2019

    Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.

  8. Investigator Site Turnover: The Importance Of CRO Support 4/27/2018

    How to offer superior value-add by enhancing a site’s clinical trial experience for improved outcomes, strengthening the relationship and positioning sites for future trial success.

  9. Improving Regulatory And Operational Performance In Orphan Drug Development 7/30/2019

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

  10. How To Boost Disclosure Efficiencies With Outsourcing 11/1/2018

    In this webinar, you’ll hear about exciting new advisory and managed disclosure services from TrialScope, including: compliance, policy and process assessments, as well as plain-language summaries, protocol registration, results posting, and redaction services.