Keen Scientific works with pharmaceutical, biotechnology or medical device companies, or contract research organizations to produce clear, concise documentation at all stages of clinical development. We also provide document templates (which incorporate current regulatory agency guidance) or work with yours. Our team can manage the synthesis of the documentation, the review process with your internal clinical and regulatory teams and the final quality control to meet tight timelines.
Clinical Clinical Study Protocols:
Our team crafts clear, comprehensive protocols necessary for the conduct of phase I through IV clinical trials. We work with your internal team to ensure that study investigators have clear instructions. We also prepare global and country-specific amendments.
Upon completion of the protocol, we can also deliver the shell for the clinical study report.
Clinical Study Reports (CSRs)
We synthesize concise CSRs summarizing the essential results for regulatory submissions. We also work with your clinical study personnel to deliver the final components of the study report in ICH E3 format.
From a completed clinical study report, we can prepare lay summaries, journal article manuscripts, congress abstracts and posters, and slide decks to report your study findings.
Patient safety narratives
We can distill relevant and up-to-date information from CIOMS reports to craft accurate safety narratives of serious and significant adverse events for each patient. Our narratives will follow the requirements according to ICH E3 Section 12.3.2.
Investigator Brochures (IBs)
Keen Scientific can provide clear summaries of a product’s non-clinical and clinical development and post-marketing experience necessary for investigator use. We also deliver IB updates by conducting literature searches and incorporating data from biostatistics and pharmacovigilance units.
Informed Consent Forms (ICFs)
Providing complete lay summaries outlining the study details, benefits and risks is key to empowering your prospective clinical trial subjects and their representatives.
Regulatory Common Technical Document (CTD)
We accurately summarize the clinical development program (Module 2, sections 2.5 and 2.7) for your CTD submissions according to ICH M4 requirements. We ensure timely delivery of regulatory reviewer ready content.
Investigational New Drug (IND)
We provide the documentation required for IND submission including investigator brochures, first-in-human study protocols, summaries of pharmacology and toxicology information and any other previous human experience with the drug.
Pediatric Study Plan (PSP) and Pediatric Investigation Plan (PIP)
We outline the pediatric study programs our clients plan to execute, being mindful of the physiological, developmental and pharmacological differences from pre-term newborn to adolescence.
New Drug Application (NDA) and Biologics Licensing Application (BLA)
We support the submission of applications to market new drugs and biologics by providing summaries of clinical development programs in CTD format. We also support abbreviated applications (ANDAs).
Clinical Evaluation Report (CER)
We deliver summaries of the clinical evidence required for licensing of medical devices according to the European Union’s Medical Device Regulation (MDR) requirements (EU 2017/745). We provide CERs for class I through III devices.
Risk Evaluation and Management Strategy (REMS)
The FDA may require a REMS before or after approval of the therapeutic product. Our team can work to provide a summary of specific safety measures to risks unique to the product including communication plans to healthcare professionals or content for package inserts.