Medical Translation Services for Safer Medicine Everywhere

A measure of confidence for global studies

The complex and increasingly regulated process of adapting COA instruments for use in global research studies demands that we keep on top of the latest guidance on linguistic validation methodology as well as eCOA adaptation, including FDA PRO Guidance, EMA guidelines, ISPOR Good Practice recommendations, C-Path Best Practices for ePRO Implementation, developer/copyright holder–specific requirements, and more.

From site identification to close-out, clinical document processes and operational oversight are complex. 

Our electronic trial solutions simplify your clinical operations by expediting timelines, enabling collaboration, improving quality, capturing the full story of the study, and passing inspections. 

Reduce Risk and Expedite Timelines with Author-to-Archive eClinical Solutions

We provide eTMF (Electronic Trial Master File) and TMF services, Content Management, Clinical Trial Management, Learning Management

 We understand your clinical trial documents and translations need more rigorous quality control and accuracy than other types of documents. There's no room for delays and errors that affect data collection. 

Our acute understanding of the needs and challenges associated with the development process and the regulatory guidelines have led us to perfect our ISO-certified workflows that match your requirements. We have a rigorous linguist certification program and only work with experienced medical translators.  

 Achieve 100% compliance with drug safety reporting timelines while reducing localization costs by 30% 

We help streamline the collection, processing, tracking, and reporting of cases as part of the PV process, and we ensure that your organization is putting patients safety first. 

We ensure global understanding of final product label content for your drug, including prescribing information, SPCs for healthcare professionals and regulators, package labeling and inserts, and more. We validate your label content in order to ensure that it is accurate, complete, and compliant in every market and language you require.  

 We translate and validate primary, secondary, and/or tertiary drug labels for investigational drugs, placebo, comparator drugs, or auxiliary medicinal drugs used for clinical protocol endpoints—and help you meet GMP standards for accurate, compliant drug labels in all markets.  

 We help ensure safe use of your medical device with our high-quality, compliant translation services for product inserts, instructions for use, packaging materials, technical manuals, and user guides.

We understand the challenges, complexities, and regulatory restrictions governing the life sciences industry.

Our digital multilingual marketing team puts significant time and effort into producing source-language copy and creative content to produce highly effective campaigns that achieve regulatory compliance for a global impact. 

Exactly what types of therapies are considered alternative? The definition changes as doctors test and move more of them into the mainstream.

Ayurveda, Hela Wedakama, Acupuncture, Chiropractic Medicine, Energy Therapies, Magnetic Field Therapy, Herbal Medicine, Therapeutic Touch, Healing and more, we cover all the areas.