Literature Review and Meta-Analysis
Systematic Literature Review
A systematic literature review (SLR) is a crucial component of clinical evaluation for regulatory submission. An SLR identifies relevant efficacy and safety data for your medical device (MD), software as a medical device (SaMD), or similar existing devices. An SLR helps prove your device’s intended use and clinical claims—demonstrating that it’s safe, presents minimal risks, or offers benefits that outweigh potential risks. Ideally, it should also show that your device outperforms existing alternatives.
Conducting an SLR involves gathering and analysing pertinent clinical literature from peer-reviewed publications, medical guidelines, and reports. This process requires a meticulous approach to ensure reliable and comprehensive results. Without a well-defined, streamlined strategy and the right expertise, this process can be time-consuming and challenging. Medical device regulatory authorities (e.g., European Union) require individuals performing clinical evaluations to have essential qualifications and skills in:
Research methodology (including clinical investigation design and biostatistics)
Scientific information management (e.g., scientific training and experience in systematic review and clinical data appraisal)
Medical writing (e.g., postgraduate experience in medicine or biomedical science)
At Precision Statistics, we recognise the complexity and importance of conducting a thorough SLR for regulatory approval. Our team of scientific experts in clinical medicine, epidemiology and biostatistics can help you execute this critical process efficiently and effectively.
Literature Reviews Tailored to Your Needs
In addition to meeting regulatory submission requirements, systematic literature reviews (SLRs) and other types of literature reviews can help you understand published evidence and inform your medical device’s value proposition, product development, market access, and post-launch strategies in the appropriate healthcare context. A robust evidence base from literature reviews can help you make informed decisions about:
Epidemiology and unmet needs in the target patient population
Your medical device’s unique value proposition
Requirements and design needs for future clinical trials
Appropriate health economic modelling and reimbursement strategies
Market access, commercial, and pricing strategies
Various options for literature reviews are available, including:
| Type of Review | Description | Use Cases | Typical Timeline* |
|---|---|---|---|
| Systematic literature review | Comprehensive identification of all evidence related to the research question, building a complete, unbiased evidence base | Regulatory submission | 4–6 months |
| Rapid targeted review | Accelerated review of a specific topic using streamlined methodology | Inform timely, resource-efficient strategic decisions | 1–4 months |
| Scoping review | Overview of literature in a particular area, using a predetermined number of articles | Identify unmet needs, evidence gaps; inform future clinical trial design | 1–2 months |
| Umbrella review | Analysis of existing systematic literature reviews in the relevant disease area and field | Compare different treatments for the same condition or the same treatment for different conditions | 1–2 months |
| Living review | Continuously updated review incorporating new evidence | Curate an evolving knowledge base for various future applications | Ongoing |
*Timelines vary due to the number of conditions, number of literature, meta-analysis requirements, etc.
The type of literature review will depend on your project goals and long-term clinical evidence strategy. Talk to our in-house expert team, who can guide you to find the best evidence methodologies to meet your needs.