You have a good pharmaceutical product, but you want to test its safety and efficacy. Eternus Global is ready to assist you in every step of the way from concept to marketing.
Stage I: Planning
You already have an idea but you don’t know how to start. Eternus Global offers medical research services that gather all relevant studies and clinical trial reports that are relevant to your area of interest. We offer evidence-based data which can help predict your compound’s safety and efficacy as well as its market potential and licensing requirements. We also offer regulatory and importation/exportation consulting.
Stage II: Animal Studies
Does your investigational product lack animal studies? We can find an animal research center for you and assist you in compiling evidence in terms of safety and efficacy of your product.
Stage III: Human Studies
Now that you have proven that your product is safe and effective in animals, the next step is to test it among humans. Phase I involves studying pharmacokinetics particularly oral bioavailability and half-life of the drug. It also tests the drug in healthy individuals for dose ranging. Eternus Global can help you design Phase I clinical trials and write protocols and study reports.
After this, the drug undergoes Phase II testing, which involves testing of the drug on patients to assess efficacy and safety. Phase III involves testing of the drug on a group of patients (1000-2000) with the target disease to assess efficacy, effectiveness and safety. Again, Eternus Global can help you in the research design, planning and writing protocols and study reports, as well as statistical analysis.
Stage IV: Marketing
We can assist you in marketing and advertising your products. We can do market analysis, segmentation and targeting offline and online. We can also write marketing copy for your products.
After your drug is approved, it should undergo post-marketing surveillance. We can assist you in compiling adverse events and in performing further research.
MEDICAL & REGULATORY WRITING
Eternus Global offers medical writing services for pharmaceutical companies, medical practitioners, students, researchers, and contract research organisations. We have expert knowledge and experience on the pharmaceutical industry, clinical research organizations, and academia.
Our medical writing services include:
- Website content
- Marketing materials
- Conference materials (abstracts, poster presentations and slide sets)
- Slide sets for healthcare professionals, CMEs and pharmaceutical industry
- Product Monographs, Newsletters
- Training modules
- Q & A and FAQs
- Manuscript writing
- Journal/conference submission
- Product website content (for both scientific and patient audiences)
- Educational material for patients, healthcare professionals and pharmaceutical industry personnel
- Medical marketing reviews and reports
- Literature reviews
- ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV
- Study Protocols
- Investigator Brochures
- Case Report Form (CRFs)
- Patient information including Informed Consent and Patient Brochures
- Standard Operating Procedures (SOPs)
- Statistical analysis/ Biostatistics