TransPerfect offers an array of solutions to facilitate the creation, management, translation, and storage of clinical documentation.

TransPerfect is proud to offer Trial Interactive, our 21 CFR Part 11 compliant, web-based e-clinical solution that enables life sciences organizations to streamline the execution and commercialization of global clinical trials and post-marketing programs in a controlled paperless environment while improving transparency.

Trial Interactive solutions include:

To learn more about Trial Interactive, visit our dedicated website HERE or contact one of our life sciences solutions specialists HERE.

When dealing with pharmacovigilance and safety case reporting globally, two things are of vital importance: speed and accuracy.

TransPerfect’s safety solutions offer you the ability to:

• Rapidly receive / process cases and communicate potential safety concerns or findings to regulatory authorities through TransPerfect’s 21 CFR Part 11 compliant safety reporting platform, Trial Interactive, as well as via our global call center that can handle over 170 languages
   
• Quickly and securely collect, track, and share safety data from investigative sites with Safety Notification Letters with a full audit trail of activity
   
• Translate SAEs and SUSARs from the investigative site or market’s native language, including rush and handwritten requests

For more information on our safety solutions, contact a TransPerfect pharmacovigilance specialist HERE.

TransPerfect’s linguistic validation group specializes in the translation and linguistic validation of Clinical Outcome Assessments (COAs) spanning a variety of therapeutic areas. Our life sciences solutions are designed with global clinical trials in mind, ensuring that you meet deadlines, shorten time-to-market, and mitigate risk. By translating over 300 COAs per year, TransPerfect has the in-depth expertise to ensure that your instrument will be culturally and conceptually equivalent in all languages, and that you will be in full compliance with regulatory authority requirements. Your COAs can be stored in the COA library for easy retrieval and / or reporting by relevant company stakeholders and key vendor personnel.

• Translation and Validation for Clinical Outcomes Assessments
• Licensing and Copyright Support
• Translatability Evaluations
• eCOA Integration and Equivalence Testing
• Study Binder Formatting
• COA Library and Document Management

In the life sciences industry, launching a new product is always a challenge. The process becomes even more complicated for a global launch, as regional nuances can mean the difference between a successful and a mediocre release.

For over 20 years, TransPerfect has assisted life sciences companies with global, regional, and country-level product launches. Offering multiple services and solutions customized to meet the needs of each brand, TransPerfect has helped the world’s leading pharmaceutical, biotechnology, and medical device companies successfully launch products throughout the world.

Our offerings include:

• Focus groups and in-depth interviews for each country of launch to strategically target your message for the right audience
• Cultural consulting to ensure patients and physicians hear the right message in the right language
• Development and localization of e-learning modules for your sales teams and/or physicians in each region
• Website localization and hosting to support your brand in over 170 languages
• Translation of brand marketing such as patient materials, videos, and much more
• Global call centers to provide medical information support and collect pharmacovigilance and safety information required by regulatory authorities throughout the world

TransPerfect’s creative services group works directly with your marketing teams and agencies to help produce a holistic strategy to support the marketing and commercialization of your products. Our agency-style approach means that your multilingual campaigns and materials are as well-crafted and impactful as the source language creative and copy that you work so hard to create.

Ensuring proper standards, policies, and procedures are being used by employees, investigators, and site personnel around the world often calls for e-learning and remote training courses. For multinational trials, these materials need to be in the trainee’s native language in order to ensure greatest impact and retention. TransPerfect has a dedicated training and e-learning group that partners with you to guarantee your globally dispersed workforce meets your standards, with services that include:

• Training Course Authoring
• Cultural Consulting
• Translation and Localization
• Voiceover / Subtitling
• Delivery & Compliance

For more information on our e-learning group, please contact us HERE.