Pharmacovigilance Services

Trans-Net provides resources to manage, enter and code adverse drug reaction reports in your local drug safety system, no matter whether you are using Clintrace, Argus Safety, ARISg, Oracle AERS or any customized system. As our employees are also clinical data managers experienced with many kind of drug reactions and interactions from clinical trials, they will help you with the quality review, labeling, evaluation and follow-up management of the cases as well. Our health professional personal will be able to support you with medical evaluation, narrative writing and causality assessment of the cases.

Trans-Net acts as "Third Party Service Provider" for pharmaceutical companies to report individual case safety reports (ICSRs) to the EudraVigilance Gateway online.

Data Management

Trans-Net's data management services flexibly supports the data management processes by providing services including:

• CRF design
• Database and validation setup
• Data-entry
• Cleaning of data
• Monitoring
• Statistical Analysis
• Report writing

Trans-Net offers to either conduct entire studies or to just take parts of it. We work with paper-based or EDC trials. As each of our data management team members is able to conduct the entire trial, from CRF design, over study setup, to validation check programming, managing queries, communication with the investigators and coding of clinical terms (WHO-DD, MedDRA, ICD, etc.), you have one competent contact person for ALL trial related questions.

We work on the projects either in-house, on-site or via secure connection to your systems.

Consultancy

Trans-Net supports you selecting and implementing business infrastructure like clinical data mangagement systems, data warehouses, pooling systems and interfaces to the existing structure, according to user and business requirements. We accompany you through the whole process of the development life cycle and we act as mediator between business and IT as we are experienced in BOTH areas.

With our own developers we help you customizing software to fulfill your specific requirements. For newly introduced applications we support you with the validation process and assure that your and regulatory requirements are fulfilled.

We are also able to support you with the transition from your company's study design standard and workflow to CDISC conform data models like ODM, SDTM, ADaM, LAB, etc. and CDISC conform operations.

Support

Trans-Net installs and configures Oracle database servers in customized environments and develops and validates additional packages needed for business requirements.

We actively support your team with our knowledge with clinical relevant systems (Clintrial, Clintrace, Argus Safety, Oracle AERS, etc.) by take over tasks like distribution of meta data, user access management, study set-up and validation, dictionary updates, data reconciliation and reporting. With our experience in data management and software development we track and follow gaps and problems in the clincial systems and communicate them to the vendor to find solutions or recommend workarounds.

Trans-Net helps to reduce the time for productive rollout and manages peak activities by set-up and validate new studies in your preferred CDMS.

Training

Trans-Net organizes workshops and trainings for the pharmaceutical industry since the beginning of the company. We help to train newly hired employees to fit the requirements of your company.

The workshops/trainings span business related software like Clintrial, Clintrace, Argus Safety, Oracle Clinical, Oracle AERS or others. Also programming techniques required for consistency check set-up, common support problems or even development tasks are possible training topics. All trainings and workshops are arrranged either at your site or in our house.

General

As we have a permanent licence from the german authority to supply temporary workers ("Erlaubnis zur gewerbsmäßigen Arbeitnehmerüberlassung"), we can offer you flexible solutions in case of project specific peaks, production rollout phase or others.