Integrating data for submissions can be a laborious and difficult task, even with CDISC data, it can be a mammoth undertaking but when we add legacy data in the mix then it can make things far more difficult. One of the ways of ensuring your approach to integration is effective is to have a good…
Integrating data for submissions can be a laborious and difficult task. Even with CDISC data, it can be a mammoth undertaking but when we add legacy data in the mix then it can make things far more difficult. One of the ways of ensuring your approach to integration is effective is to have a good…
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…
Background In 2018 we at CROS NT supported a small pharmaceutical company with a complicated Integrated Data Package and Summaries of Safety and Efficacy that was required for an FDA submission. This challenging data harmonisation project our client requested involved multiple studies in various phases from I to III. Challenge Our experienced teams are used…
CROS NT looks at the regulatory requirements from both the EMA and FDA with regards to Integrated Summaries of Safety & Efficacy and how to successfully prepare these analyses from a statistical and documentation point of view. Integrated Summaries of Safety and Efficacy are not only required for New Drug Applications, they are considered some…
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…
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…
One of the most challenging aspects for sponsors is the ability to create comprehensive information from clinical trials for new drug applications that will meet the stringent requirements of the Food & Drug Administration (FDA) and the European Medicines Agency (EMA). Integrated Summaries of Safety and Efficacy are not only required by these agencies but…
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…
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…