Systematic literature reviews
If progressing with either a literature-based or hybrid TGA application, a systematic literature review is required. Systematic literature reviews are more than simply entering key words into your PubMed or Embase search. Ahead of even assessing the supportive literature, the TGA will seek to understand the search has been undertaken in such away that it is reproducible and without bias. We pride ourselves on our ‘slick’ process for undertaking systematic literature searches, identifying and applying exclusion criteria, and preparing the relevant clinical, non-clinical CTD modules as well as Module 1.5.1.
We also offer what we call feasibility-based systematic literature reviews. These feasibility-based systematic literature reviews help to understand whether a systematic literature review would contain sufficient information for a TGA literature-based or hybrid submission. They are also helpful in cases where literature support is required but the effort of a systematic literature review is not needed.
Here are some of the ways a feasibility-based literature search can add value to your project:
- Summarise relevant clinical trial data
- Summarise relevant in vitro and/or in vivo animal study data
- Identify reported adverse events
- Explore the effect of applying different exclusion criteria to the search output.
- Identify the strength in literature support ahead of locking in a literature or hybrid based regulatory strategy.
Contact Enimera RegPlus to enquire about our pricing options.
Non-systematic literature reviews
Non-systematic literature review are helpful in keeping up with developments of interest. We run one-off or regular literature searches by active ingredient, by author (name or organisation), by indication, and also by other criteria as relevant to you, with reports delivered straight to your inbox.
Contact Enimera RegsPlus to enquire about our pricing options.
If you’re after a systematic literature review to understand strength of evidence or to support your regulatory submission, contact the Enimera RegsPlus team. We are experts in systematic literature and non-systematic literature reviews.
