Your favourite blog posts 2020 on Life Sciences trends

Your Favourite Blog Posts from 2020

In 2020, we worked hard to keep you updated on main trends of Life Sciences world. We covered a whole range of topics from risk and mitigation during COVID-19 pandemic to clinical trial design in small populations and building a robust EDC system. You can find the full list of our expert articles in the…

5-steps to effective Integrated Summaries

5 Steps to Effective Integrated Summaries

CROS NT has extensive experience in planning, managing and implementing the work required for data integration when preparing integrated summaries, both for ISS/ISE and for CTD dossier submissions. Every project is unique, and our programmers and statisticians are expert at tailoring reporting requirements in order to efficiently and effectively meet the needs of the client…

integrated summaries

How to Keep Integrated Summaries (ISS/ISE) Projects Under Control

Costs associated with integrated summaries of efficacy and safety (ISS/ISE) can be burdensome for some Sponsor budgets – with increases arising from all sorts of factors from consistency issues to meeting tight timelines. How can these costs be reduced and timelines maintained? Gap Analysis The key to faster and more efficient preparation of ISS/ISE lies…

Avoiding High Charges from CROs for Integrated Summaries

Avoiding High Charges from CROs for Integrated Summaries

Integrated Summaries (ISS/ISE) are often required by health authorities when submitting a new drug application. It is important to note that integrated summaries are not simply study summaries, but rather they are an analysis of results that determine the safety and effectiveness of drugs in development. ISS and ISE are also an integral part of…

Integrated Summaries of Safety & Efficacy: Considerations

Analysis Considerations for Integrated Summaries of Safety & Efficacy

Statisticians and statistical programmers are crucial team members in planning, producing and presenting integrated summaries. Planning well in advance for ISS/ISE is the first step in saving time and money. Statisticians will need to outline the specific issues that the integrated summary will need to cover and should attend pre-submission meetings with regulatory authorities to…