Drug development

1. Medical Writing

NEOX has provided comprehensive medical writing services for all stages of clinical research from protocol planning to publications of trial results in peer-reviewed scientific journals. Except for broad expert medical knowledge, our writers are familiar with regulatory and legislative requirements of an extensive spectrum of trial-specific documents including unwritten rules of usual practice. We also have certified translators into English and local languages who are well accustomed to performing precise translations of expert terms both for clinical trial and medicine, call attention to regulatory and/or legislative requirements not fulfilled in the document and modify the language as needed for the target reader (plain language in Informed Consent Form versus expert language in Clinical Study Report).

We regularly create the following documents:
  • Protocols for both interventional and non-interventional trials or investigations
  • Informed consent forms including information on data protection as needed even for vulnerable subjects
  • Data management plans, statistical analysis plans, monitoring plans, site operational manuals, etc
  • Clinical study reports – interventional trials, non-interventional trials including product or disease registries
  • Manuscripts, posters, and presentations for the trial result publication

2. Site Contracting

Due to our long-term experience, we select and recommend reliable sites for your clinical trial in the relevant medical specialty enter into contracts. We have experienced lawyers who are familiar with local legislative specifics in countries both in and outside the European Union.

3. Clinical Monitoring

Our clinical monitors are thoroughly trained to perform clinical monitoring as required according to GCP and the other relevant legislation. On top of these requirements, our monitors adjust monitoring activities to sponsor SOPs or needs including remote data capture, on-site visits, or other forms of monitoring.

4. Project Management

We manage all aspects of the clinical trial from the very early stages of protocol designing, eCRFs creating and feasibility research to data analysis and clinical study report writing, or even trial result publications. Our project managers cooperate with all NEOX departments: regulatory, legislative, pharmacovigilance, quality control, data management, statistics, and medical writing to achieve reliable high-quality performance in clinical trial conduct.

5. Pharmacovigilance/ Regulatory

Our pharmacovigilance department provides 24-hour service to collect serious adverse events from clinical trials or other types of safety records and offers management of all types of safety reports as required by applicable regulations. Our PV experts will advise you on specific needs of safety monitoring for variable types of clinical research including first in human studies, post-marketing safety studies, or clinical investigations of medical device studies.

Our Regulatory Affairs team are local experts who hold vast experience and extensive knowledge in national guidelines and procedures, key aspects of the local regulatory processes, and documenting management practices.

  • Multi-national and global submissions including biologics, GMO, medical devices, and vaccines
  • EU VHP support

6. Medical Monitoring

Our experienced medical advisors communicate specific medical needs of each trial with key opinion leaders in the relevant therapeutic area during trial planning. Our data managers routinely design eCRF with an automatic quality check for entered data (range, date, mandatory/optional data collection) or perform data clarification requests.

7. Outsourcing

We provided experienced monitors, line managers, clinical operation managers, regulatory and safety assistants to prestigious pharmaceutical companies for many years. We established a successful partnership with these companies and provide our employees for both short-term and long-term periods as needed. Except for outsourcing our specialists, we perform individual or all activities in the conduct of clinical trials on a contractual basis on the sponsor's behalf.