Hands-On Medical Writing
Apart from getting a go-ahead from the medical authorities concerned, a well-written clinical study protocol is a prerequisite for conducting a clinical study. It can also help attract the attention of potential investors to the project. Ewa Hedner, owner of Inertia AB Clinical Science knows more.
When an idea develops successfully it eventually matures enough to be tested in humans, in clinical studies. It’s an interesting and exciting phase, but there are several things to consider.
All stages in a clinical study must be carefully planned. There are ethical considerations that must be taken into account as well. In addition, the medical products to be tested and the study design must be reviewed and approved by medical authorities. Hence, a well-planned and well-written study protocol is a prerequisite to obtain approval from authorities to conduct a clinical study.
”It’s also good to have a detailed clinical study plan when discussing the project with potential investors, since it shows how you’re thinking and calculating on the project. It gives a clear picture of what the costs are and time needed to invest in your company,” says Ewa Hedner, PhD, Dentist and owner of Inertia AB Clinical Science, a single-member consulting company offering professional and cost-effective medical writing services.
Gaining human data at an early stage is important for decision on how to advance the clinical programme, deciding on any complementary pre-clinical steps, as well as in communicating the business potential to would-be investors.
Situated at Sahlgrenska Science Park
”I have broad scientific competence and offer hands-on medical writing, covering the clinical study process; including planning and study design, clinical study protocol, applications to medical authorities, including ethics committees and the Medical Products Agency, patient informed consent, case record form, study monitoring, study report, scientific publication. Everything is done in accordance with ICH/GCP and regulatory demands,” she adds.
Situated at Sahlgrenska Science Park, Inertia is well positioned close to the clinics at Sahlgrenska University Hospital and the SMEs clustering on Medicinareberget.
”Most of my customers are academic research groups and life science SMEs, though I’ve also taken on projects from AstraZeneca, Astra Tech and Gothia Forum. I’m primarily involved in drug development projects and would like to add more medical device projects to my portfolio,” Ewa Hedner concludes.