Life Sciences

From IFUs and SmPCs to marketing solutions, from medical software localization to CRO materials, quality, precision and clarity of language help maintain the global presence and facilitate the global growth of the industry.

Our Solutions for Your Life Sciences Business

Ciklopea’s medical and pharmaceutical linguist teams are highly experienced in localization and translation of various life sciences-related materials.

Patient Information Leaflets (PIL)

Patient information leaflet (PIL) or package insert is a summarized, patient-oriented version of Summary of Product Characteristics (SPC).

PIL is a digital or printed document featuring specific information on medical conditions, doses, side effects and other medical product details that can be easily understood by patients and users of medical products.

Patient information leaflets are composed by manufacturing companies and delivered with the medical products.

Designed to convey the accurate pharmaceutical data in a manner clear to common users, PILS are translated and localized by experienced multidisciplinary expert teams with the required skills for clear, concise and accurate adaptation of medical and pharmaceutical content to a foreign market.

All PILs at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Summary Of Product Characteristics (SPC)

Summary of Product Characteristics (SPC or SmPC) is a structured document featuring detailed information on drugs, medicines, supplements and other medical products.

Composed by manufacturing pharmaceutical companies for licensing purposes from European and local regulatory bodies, SPCs are the most detailed and most accurate descriptions of medical products.

Summarized, patient-friendly versions of SPCs are PILs.

Written by pharmaceutical and healthcare professionals for their peers, SPCs are translated and localized following the strict procedure and using the expertise of highly experience multidisciplinary teams.

All SmPCs at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Study Protocols

Clinical trial protocols, research protocols or study protocols are the documents that feature highly detailed information on a clinical study, including the study objectives, design, methodology, number of participants, eligibility, exclusion criteria, therapy information, study endpoints and more.

Structured study protocols are required for validity of all types of clinical trials, including case studies, case-control studies, cohort studies, randomized controlled trials (RCTs), blind and double-blind studies and meta-analyses.

Composed by pharmaceutical and healthcare professionals for their peers, clinical trial protocols are translated and localized following the strict procedure and using the expertise of highly experienced multidisciplinary teams.

All study protocols at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Questionnaires

Clinical trial questionnaires are structured, both patient-oriented and expert-oriented digital or printed documents that feature sets of questions covering all aspects of a clinical study.

Composed by medical doctors or research groups, the questionnaires are answered by study participants and assessed by the research groups.

Questionnaires form a pivotal part of every clinical study as precision and clarity of answers and the collected data is directly dependent on the quality of questions. This is why questionnaires are localized and translated by interdisciplinary expert teams with rich experience in medical translation and localization.

All clinical study questionnaires at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Informed consent forms are structured patient-oriented digital or printed documents designed to provide guidance and detailed information on study objectives, nature, risks and other information to the study participants.

Designed by health care workers or research groups, the informed consents are collected before the clinical trials and confirm that all parties are fully aware of all aspects of the study.

Informed consents must contain detailed, clear, accurate information that can be fully understood by non-professional trial participants. As such, informed consent forms are localized and translated by interdisciplinary expert teams with rich experience in medical translation and localization.

All informed consent forms at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Labels

Medicine labels or healthcare labels are the tags placed on the packages of drugs and other pharmaceutical products featuring the product name, dosage, warnings and other basic information.

Primarily designed for patients and composed in accordance with a number of regulatory and safety guidelines, over-the-counter (OTC) medicine labels are an important part of a healthcare product that are localized and translated by interdisciplinary expert teams with rich experience in medical translation and localization.

All drug labels at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Marketing Materials

Marketing materials for life sciences include a wide range of digital and printed marketing items used to support the sales and promotion of medical, healthcare or pharmaceutical products or services.

Life sciences promotional items range from the traditional marketing materials such as sales brochures, web content, catalogs to the industry-related marketing collateral such as white papers, case studies, newsletters, product data sheets and more.

Localization of marketing materials for the life sciences industry requires expertise of  linguist teams with marketing and medical / pharmaceutical industry background.

Patient Reported Outcomes

Patient-reported outcome or PRO is a type of measure used in the clinical studies. PRO is a self-report, written by the patient or composed in the form of interview and for this reason it provides a unique perspective to the drug approval process from the patient’s viewpoint.

Although patients included in a clinical trial may also be medical professionals, this is usually not the case and for this reason translation and localization of PROs must be performed by highly experienced multidisciplinary expert teams with linguistic proficiency and medical industry background who will be able to communicate the patient’s perspective in a clear and accurate way.

All life sciences materials at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Communication with Local Regulators

All clinical trials must be evaluated and approved by the local regulatory bodies.

Clear and accurate communication between the sponsors, study centers and regulatory bodies is essential for success of every clinical study and for this reason translation and localization of all communication must be performed by highly experienced multidisciplinary expert teams with linguistic proficiency and medical industry background.

All life sciences materials at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.

Contact Us With Your Request

Request a Quote

Fill in the form and we will contact you ASAP.

More Questions?

Our language specialists have the answers.

Resources and Articles on Life Sciences

Industry Focus Drives Quality

Ciklopea provides linguistic solutions for two more industries:

Specialization creates more room for perfection.