Commission of safety information management
We support your safety information management through our experience and know-how
We have engaged in safety information management-related business since 1998 and have dealt with drug safety information starting from preparation of MS-Word-based CIOMS and reports for the regulatory authority submission. We support the pharmaceutical and medical equipment companies’ safety information management through our many years of experience, know-how and dedicated personnel.
We build business systems according to your specifications
From clinical studies to post-marketing, we at WysiWyg can handle projects ranging from small to mid or large-scale with flexible number of staff members allocated.
We also adjust to your needs depending on whether the chosen work model is on-site (at the customer office) or off-site (at WysiWyg). As an example, we can provide a flexible work model where a number of personnel are stationed at the customer’s office and handle reception, case archiving and progress management, while input and translation are conducted at our office.
Translation of safety information
We conduct case translation that demands medical precision and on-time delivery
We offer services where we translate clinical courses (narratives), physician’s comments etc. for the evaluation of safety information that pharmaceutical and medical equipment companies have obtained. Our translations are accurate, precise and always meet the deadlines set by headquarters and overseas partners.
Not only do we translate report information (clinical course, physician’s comments etc.), but to aid the evaluator, we also select the correct terminology, adhere to description rules, avoid contradictions in terms of background information and perform medically correct translation in timely manner.
We also offer case translation in English so that the institutions can report clinical courses and comments in English directly to an electronic data capturing (EDC) system. By offering translation directly to clinical study institutions, we preserve a workflow where the intention of the customer (pharmaceutical and medical equipment companies) does not intervene.
We conduct creation or translation of various documents or formats required for safety information management
We undertake translation and creation of various documents required in the safety information management business including the preparation of drafted reports for Japanese and overseas regulatory authorities, the preparation of reports in designated formats (CIOMS etc.) for overseas partners, drafted narratives and line lists, and the translation of package inserts and articles.
We offer our customers a quick and high-quality translation grounded in over 20 years of experience in safety information management together with our internal medical experts and know-how which we as a scientific and medical translation company have cultivated.
We also offer our customers evaluation support services, stretching from obtainment of literature to literature evaluation for reportability to the regulatory authority. With rules decided together with the customer, we perform literature screening to confirm whether all necessary information (ADR (adverse drug reaction) report, research (study) report) is included or not.