Published on Saturday September 30, 2017
Smooth Drug Development August-September 2017 News ReleaseThe company starts working on several new projects:
- The company has been assigned to provide consulting services of the quality system expert evaluation at two pharmaceutical manufacturing sites in China, as a part of state drug registration services.
- Two projects on literature reviews of scientific papers are in progress. The topic of the papers is preclinical and clinical studies of medicinal products and their results (INN: Oseltamivir, INN: Azithromycin). The projects are sponsored by an international pharmaceutical company.
- The company has started a bioequivalence study of the drug (INN: Amlodipine + Valsartan + Hydrochlorothiazide). This is another project from our loyal customer. * The development of a scientific paper literature review is in progress. The paper includes results of preclinical and clinical studies of the drug (INN: Amilnitrite). We are glad to receive such tasks from our loyal customers; these projects have become a frequent practice for our company.
- The company has started a bioequivalence study of the drug (INN: Etoricoxib). This is the first experience of cooperation with the German international pharmaceutical company.
- The company has started working on the project, that previously won a tender for data processing services. The project includes biomedical statistics and writing a final report on the drug study (INN: Adalimumab) in routine practice. The project is going to be interesting and versatile.
- The medical documentation development for three new projects has started: (INN: Pantoprazole, INN: Iwabradine, INN: Clopidogrel + Acetylsalicylic acid). The request for this kind of services we receive from one more of our loyal customers on a regular basis.
- In the project for the Phase III clinical trial of the drug (INN: Amlodipine + Bisoprolol + Perindopril arginine), involving patients with uncontrolled essential hypertension, the documents have been submitted to the Ministry of Health for clinical trial approval. The ordering customer is the largest French pharmaceutical company.
- In the project for the pediatric Phase III clinical trial of the drug (INN: Normal human immunoglobulin), in the treatment of patients with primary immunodeficiency, the documents have been submitted to the Ministry of Health of the Russian Federation for clinical trial approval. The ordering customer is the largest Austrian pharmaceutical company.
- In the project on the bioequivalence study of the drug (INN: Ethosuximide), the approval of the Ministry of Health of the Russian Federation has been received. This project is the second and not the last received from one of the largest pharmaceutical companies in Russia.
- The company has completed the Phase II study of the drug (INN: Ompinamer), involving patients with ARI. This project has been added to the collection of successful projects fulfilled by our company.
- In two Phase I clinical trials of drugs (INN: Choline alfoscerate hydrate + Glemax, INN: Meldonium dihydrate + Ethylmethylhydroxypyridine succinate) involving healthy volunteers, the clinical parts have been successfully completed. The ordering customer is another largest Russian pharmaceutical company.
In September, the Corporate Development Department has visited several large exhibitions in pharmaceutical industry and clinical research:
- ESMO (Madrid, Spain).
- Outsourcing in Clinical Trials New England (Boston, the USA).
- Outsourcing in Clinical Trials Southern California (San Diego, the USA).
We are glad to inform you that in october-november the Corporate Development Department will represent our company at the following conferences:
- CPHI Europe, October 24-26, Frankfurt.
- BIO Europe, November 6-8, Berlin.
- Adam Smith Conference "Clinical Research in Russia 2017", November 14-15, Moscow.