Working Time
| Mon-Fri | 10:00 - 18:00 |
| Saturday, Sunday | Closed |
Quick Pricing
| Service | commercial | non commercial |
| Per-hour cost | 50 Euro | 20 Euro |
| Success fee | negotiable | negotiable |
| Flat rate monthly fee (60 hours) | 2500 Euro | 1000 Euro |
Welcome to Our Company
If you are looking for help in the preparation, registration and conducting a clinical trial in Poland - are on the right website. Masha Regulatory Service provides comprehensive care for your project. It doesn't matter if the research is commercial or non-commercial, you are a large pharmaceutical company or an ambitious researcher - we ensure the highest quality and full commitment each time.
Mission & Vision Statement
Masha Regulatory Service was created to provide all customers with the highest level of service, taking into account the financial capabilities of projects. That is why Masha Regulatory Service is open to non-commercial research. Currently, Masha Regulatory Service is involved in several such projects. We believe in the mission of clinical research, which is why our activities are not dictated only by profit-making purposes. We are very flexible and we fully support Investigators and Sponsors in their great job.
Our Mission
We want to make a small contribution to the continuous development of medicine. Our mission is to support Sponsors and Investigators in the process of conducting clinical trials.
Vision Statement
We promised ourselves that we would work so as to provide our clients with ready-made solutions they need. We are proactive, we don't give up in the process of self-improvement, we present out of the box thinking. We do not overwhelm our clients with questions, problems, e-mails, but we act so that they themselves can focus on what is most important - patients well. For all the rest they have us :)
Company Principles
Beside following the GCP principles, we place emphasis on the human factor first. We do not divide research into profitable / less profitable. We approach each project with the utmost commitment. We are willing to exceptionally give up our rates for exceptional studies.
Services
Contact with Investigators
Feasibility, Site Selection Visits, collecting documents from Investigators
Study Sites
Preparation, negotiation and finalization of contracts for conducting clinical trials with Investigators and Sites (private and public). Preparation of specific applications required by the Sites before starting the negotiation process. Contact with local Pharmacies, Labs, collecting required documents
RA/CEC/ECs
Contact and full cooperation with competent authorities in Poland. Preparation of applications for clinical trial to the Bioethics Committee and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; regulatory maintenance; submission of substantial amendments and notifications.
Clinical Trials Monitoring
Pre-study Visits, Initiation visits, Periodic Monitoring Visits, Close-Out Visits
Study Documentataion
Preparation of Informed Consent Forms, organization of registry documents sworn translations, powers of attorney preparation, assistance in providing local insurance, preparation of investigational product labels, preparation of necessary documentation to conduct the study together with translations to local language
Clients Testimonials
In my project, Anna actively communicated with the Sponsor, proposing solutions that did contribute to faster approval of the Voluntary Harmonization Procedure (VHP) for 11 countries. In addition, she cooperated with local regulatory authorities, which resulted in approvals for the study, issued without any reservations and within the assumed deadlines. During that time and after study approval Anna continued to support investigators to ensure proper circulation of documentation and contract negotiation processes.
Anna is a person with great communication skills, which resulted in very good cooperation with local competent authorities. At the same time, she has an easiness in decision-making and is a very hardworking person. I believe that it will be a huge support for a smooth process of start-up in the clinical trial. I would like to recommend Anna to further cooperation.
Anna is a very versatile person who is well oriented in legal and accounting matters her help in these fields has proved to be very significant. She easily communicates with various hospital departments, she acts very professional while remaining a nice and enthusiastic person.
Please let me know if I can provide any more information to strengthen Anna's candidacy. She has a very special spark, and I trust she will go far in clinical trials.
I am pleased to write a letter of recommendation for Masha Regulatory Service. I am writing this letter on behalf of the P****-3 Project Office, a trial office operating under the Population Health Research Institute (PHRI) in Hamilton, Ontario, Canada. The P****-3 Project Office (Sponsor) has collaborated with Anna since April 17, 2018, and we would like to express that Anna has provided a considerable amount of support, guidance and assistance in ensuring that the P****-3 trial has been successful in both Poland and other European countries.
Anna has been assisting our research staff in performing document translations, ensuring that the trial was compliant with Polish regulatory requirements and with Sponsor requirements, assisting in preparing the submissions and responses to both the Voluntary Harmonisation Procedure (VHP), and to Urzedu Rejestracji Produktow Leczniczych (URPL).
In addition to this, Anna has also assisted in the negotiation of four Clinical Trial Agreements (CTAs) between the participating Polish institutions and PHRI. Her excellent communication with the Polish sites and our Contracts department allowed for a smooth negotiation process. Anna has also coordinated the collection of all necessary Good Clinical Practice (GCP)-required essential documents in advance of site activation.
It has been an absolute pleasure to collaborate with Anna. Her communication with us has been outstanding, she has met all deadlines, and she has always maintained a friendly attitude. We are grateful for her efforts in ensuring the successful implementation of the P****-3 trial in both Poland and Europe.
If you require any additional details, please feel free to contact us.
Additional Services
At the client's request, Masha Regulatory Service provides professional legal and accounting assistance, including payment settlement services among the study team.