Don’t be Duped by Dupes: How Language Scientific Saved a Sponsor $1 Million
ACI Clinical Overview
ACI Clinical, located in Bala Cynwyd, PA was founded in 2001 as a specialty service provider to the clinical research industry. For more than a decade, ACI has specialized in driving best practices in managing Expert Committees that provide oversight to clinical trials, including full-service Endpoint Adjudication Committees, Data Monitoring Committees, and Safety Assessment Committees spanning the globe.
ACI’s global network of over 500 expert thought leaders serve as committee members and/or advisors to their clients. They provide bias free analytics and state of the art decision support technology to enhance trial integrity for regulatory submissions, while ultimately mitigating risks and enabling patient safety. ACI was built with a systems approach to organizational quality, and their employees care deeply about achieving customer satisfaction and performance excellence in everything they do.
Summary of Circumstances and Challenges
Circumstances:
Working within the clinical research industry comes with numerous risks. On the financial end, billions of dollars are spent annually on global clinical trials. An error during a trial can cause significant financial losses. On the other end, human lives are at stake.
To mitigate these risks, ACI Clinical’s global clients require timely, cost effective, high integrity data. With data arriving from numerous global sites, ACI requires unimpeachable translation accuracy of patient clinical data to ensure the safety and efficacy of each clinical trial. This data may include handwritten clinician notes, lab and radiology reports, hospital discharge instructions, autopsy reports as well as other information pertinent to the trial. Accuracy and timely translation of these documents are essential to the overarching timeline of each clinical trial.
Prior to working with Language Scientific, ACI’s previous translation service provider had issues meeting their original agreed upon turnaround times, thus negatively impacting the timeline for ACI’s end clients. Due to the critical nature of the services they provide, missing timelines due to late deliveries by their translation service provider could not be tolerated.
In summary, ACI needed to find a way to decrease the turnaround time required to provide high quality translations of clinical trial materials.
Challenges:
ACI faced four major challenges regarding translation for their end clients.
1. Meeting Turnaround Time Requirements
Quick turnarounds of clinical trial results are critical. Some ACI clients needed 24-48 hour turnarounds for time-sensitive trial results, and they weren’t always able to get it done in time with their previous translation vendors.
2. Translation Accuracy
Quality of translations could not be compromised even with short turnaround times.
3. Maintaining Trial Integrity
Trial participants need to remain anonymous in all documentation to maintain integrity of the results and to protect patient privacy.
4. Reducing Cost
ACI sought to reduce their clients overall spend on translation.
About Language Scientific
Language Scientific, Inc. is a U.S. based translation company located in Medford, MA specializing in clinical, medical, scientific and technical language services and solutions. The company has a proven track record of more than 20 years of excellence providing translation services in over 215 languages. Language Scientific serves more than 1,500 clients in the pharmaceutical, clinical, and medical device industries ranging from Fortune 500 pharmaceuticals to small emerging start-ups.
Language Scientific was founded in 1998 by a group of multilingual doctors and scientists in Cambridge, Massachusetts, who were dissatisfied with the state of scientific and technical translation in their professional fields. Medicine and science are distinguished from other fields of knowledge by the precision of their concepts and language. Having suffered through countless pages of inaccurate, unclear, and sometimes outright dangerous translations of clinical data, trial protocols, patents, and scientific documentation, these Cambridge scientists formed Language Scientific with the mission of setting new quality management standards for medical and technical translation.
Language Scientific has worked with over a third of life science sector companies within the Fortune 500. Their success in these markets derives from the ability to balance a flexible and innovative culture with the rigid and high standards of quality greatly exceeding the requirements of their ISO 9001:2008 and ISO 17100:2015 certifications.
Language Scientific’s flexibility comes from the observance of an around-the clock work schedule. Translations can be turned around in 24 to 48 hours depending on variables. These quick turnaround times adhere to their 12-step Quality Methodology.
Solutions
Language Scientific applied its innovative talents toward customizing an Endpoint Adjudication specific translation process unique to ACI’s particular needs. They were able to develop customized solutions to meet all four challenges that ACI faced.
Meeting Turnaround Time Requirements
Language Scientific created software to systemize and enhance the workflow through their specialized business practice group dedicated to handling Adverse Events and Serious Adverse Events (AEs and SAEs), in addition to Endpoint Adjudications. To reduce time spent during project inception, Language Scientific implemented a specialized file submission process through their Client Portal and customizable APIs, helping to save valuable time. Standard procedures for ACI were also created to better assist in meeting expedited turnaround times as well as maintaining a high quality of the translation. These are discussed in the following section.
Translation Accuracy
To provide highly accurate translations while meeting tight turnaround times, Language Scientific developed standard procedures for ACI including creation of style guides, Project Manager guides, Project Manager review checklists, delivery checklists and a project auditing process. Alongside these procedures, Language Scientific holds their linguists to some of the highest standards in the industry. To be considered for an ACI project, a linguist must meet the following requirements:
- Pass stringent Language Scientific’s accreditation and testing requirements.
- Have advanced degrees pertinent to the subject they are translating; many of the linguists hold medical degrees (typically MD) and undergone training (including Fellowships and clinical experience) in the specific area of medicine most relevant to the document.
- Be a native speaker of the target language of the translation (namely, US English).
- Meet Language Scientific Conflict of Interest and Confidentiality requirements
In addition, all Language Scientific translation projects follow a 12-step Quality Methodology to further ensure accuracy in the final deliverable.
The standard translation process for all ACI projects includes the following 12 steps:
- Assessment of the Documents
- Translation Team Assembly
- Linguistic File Analysis/ PII Redaction Identification
- Translation by a medical translator
- Editing by a separate linguist (first quality check)
- Desktop Publishing
- PII Redaction and Flattening of the Files (second quality check)
- Quality Assurance (third quality check)
- Desktop Publishing 2/ Implementation of Publishing QA Changes (if necessary)
- Internal QA (fourth quality check)
- Client Delivery
- Implementation of Client Review Comments (if any)
Maintaining Trial Integrity
In order to maintain the integrity of all ACI Clinical trials, Language Scientific established a unique process of performing multiple QA steps to ensure all patient identifying information (PII) has been fully redacted to ensure patients anonymity to comply with all patient privacy laws. Guidelines for this additional redaction step were created by Language Scientific and this step was built into the standard process for ACI. Examples of PII that Language Scientific redacts in every ACI document include:[slb4]
- Name (or family members’ names)
- Initials (or family members initials)
- Address
- Birth date (month and day) year of birth should remain
- Health plan beneficiary numbers
- Phone Numbers
- Fax Numbers
- Social Security Numbers
- Account Numbers
- Medical Record Numbers
- Electronic Mail Address (e-mail)
- Certificate/license numbers;
- Vehicle identifiers and serial numbers, including license plate numbers;
- Device identifiers and serial numbers;
- Web Universal Resource Locators (URLs);
- Internet Protocol (IP) address numbers;
- Biometric identifiers, including finger and voice prints;
- Full face photographic images and any comparable images; and
- Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data)
- Date and month of both (when applicable)
Reducing Cost
Language Scientific helped ACI reduce study costs by implementing a unique duplicate checking process. Submissions from global sites requiring translation would often include pages of information previously submitted for translation, sometimes several years prior. All submissions are scans of original documents, sometimes of poor quality, often with handwritten scribbles in the margins. They include discharge instructions, medical reports and labs. Trained Language Scientific specialists analyze each page of all new case submissions, comparing them with all prior submissions to find duplicate pages. Through this process, Language Scientific identifies pages that were either partial or complete duplicates of prior submissions. If full duplicates are detected, Language Scientific sends the previously translated document back to ACI at no additional cost. If only some pages or parts of a page were translated, LS re-uses that translation without charge. This thorough duplicate checking not only helped save millions of dollars for ACI and the sponsors, but also greatly reduced overall turnaround times.
Additional Solutions
To further assist ACI, Language Scientific established additional customized solutions to best work within ACI’s needs:
Custom Reporting
Language Scientific created customized reporting functionality geared towards ACI’s unique translation requirements allowing for real time viewing of statistics and additional information via Language Scientific’s web based portal.
Custom Invoicing
Language Scientific offers customizable invoicing options to best fit each individual clients needs.
Solutions by the Numbers
Reducing Cost
Sample Clinical Trial Savings #1
Due to duplicate checking, Language Scientific was able to save ACI Clinical over $1,000,000 during the span of this clinical trial, representing a total savings to client of 45%.
| Price | % Savings | |
| Nominal Price | $2,436,005 | |
| Cost Savings on Duplicate Detection | $1,098,099 | |
| Final Price | $1,337,906 | 45% |
Sample Clinical Trial Savings #2
Due to duplicate checking, Language Scientific was able to save ACI Clinical over $143,000 during the span of this clinical trial, representing a total savings to client of 85%.
| Price | % Savings | |
| Nominal Price | $168,149 | |
| Cost Savings on Duplicate Detection | $143,115 | |
| Final Price | $25,034 | 85% |
Sample Clinical Trial Savings #3
To further see how Language Scientific was able to save ACI Clinical money, duplicate savings for a third trial are broken out to show savings for both partial and full duplicates.
| Price | % Savings | |
| Nominal Price | $2,396,163 | |
| Cost Savings on Partial Duplicate Detection | $762,697 | 31.8% |
| Cost Savings on Full Duplicate Detection | $61,248 | 2.5% |
| Final Price | $1,572,217 | 34.3% |
Meeting Turnaround Time Requirements
Language Scientific maintained a 99.7% on time delivery rate for all ACI projects in 2017.
Maintaining Trial Integrity
Language Scientific provided redaction of patient identifying information in over 7000 projects in 2017.
