It does not work without YOUR input
Before a new medicinal product is introduced to the market, safety, efficacy and tolerability have to be tested. YOU have the experience with your product and we have the experience how to bring YOUR product to YOUR planned market.
Clinical & Medical Review / Monitoring Services
Our medical monitoring capabilities include
Pharmacovigilance / Safety
Our medical writers work with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents (e.g. Clinical Trial Protocols, Case Report Forms, Clinical Trial Reports, Patient information leaflets, Patient information, Marketing Brochures) comply with regulatory, journal, or other guidelines in terms of content, format and structure.
Medical writing is a service providing special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.
Regulatory Medical Writing
means creating the documentation that regulatory agencies require in the approval process for drugs, medical devices and biologics. Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Documents [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.
Educational Medical Writing
means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).
Medical Writing, Consultation and Training
GCP & Medical Writing Training
At LaNova Consulting, we believe in sharing our own experience with the next generation of clinical research professionals. Such a transfer of knowledge has proven fruitful, combining experience with new ideas and bringing together the latest developments from industry and academia.
By participation within the Medical Research Management – Diploma Program established in the Medical College at the AL IMAM University in Riyadh the related tasks and responsibilities according to ICH-GCP guideline and legal requirements will be discussed. The training program covers all topics of relevance for a high-quality conduct.
According to legal requirements meanwhile implemented by the Ethics Committees, physicians who want to participate in the conduct of clinical trials need proof of GCP training.
Upon request our experienced instructors also train you and your team on a spot at your investigational site or during investigator meetings.