Qualitectrials®
About the company

Qualitectrials® is a highly qualified clinical support services company, focused on clinical research and processes for the pharmaceutical, biotechnology and medical devices industry through long last B2B relationships with a high added value.
We offer a fully integrated R&D support for Phase I to Phase IV clinical trials in different therapeutic areas, with more than 18 years of experience in clinical trials management and following the highest quality standards.
A global network in managing international clinical projects in each EU country with proof experience.
Qualitectrials® was born with the aim to support the clinical research in the pharmaceutical industry, at a local and international level, commit to the success and increase the pharmaceutical company value and assets.

Qualitectrials® is part of a group of companies working in the development of the pharmaceutical industry with QualitecFarma® and with worldwide operations. The group Qualitecfarma/Qualitectrials cover the value chain of the products from development up to market access procedures and business plans. In this effort we believe in the high standards necessary for this huge investments and we are confident and proud to be part of the process whether it is with early clinical development or up to finished product regulatory procedures until the market access strategies in different, reimbursed or not, government environments.

Services
  • Protocol design
  • Site management and selection
  • Selection and KOLs access
01.
  • Ethical committees
  • Monitoring
  • Data management. CRF/eCRF
  • Biostatistics
  • Final reports
  • Pharmacovigilance
02.
  • Study and Protocol design (including Statistics)
  • Protocol submission, ECs and Has
  • Contracts management with hospitals, KOLs and principal investigators
  • Initiation, followup, close-up visits
03.

Adaption to the CDP

04.
05.

To be updated is always with the state of the art products is not easy. But old products may still be the best option sometimes, i.e. some OTCs. In this case the market leads to keep the product clinical information up to date and therofe clinical studies confirming or comparing the treatment options is the way to be still on the market.

In the case of innovative products post marketing CTs are the solid grant of the safety and efficacy of the ultimate treatments.

06.
07.

For a First in Human CT it is advisable as for HAs having a clear picture of future. Medicines development is not a step by step process but a global idea of the targets and the pathway to follow. Therefore a clear clinical development plan is advisable to get the approval for a FIH. This is also supported by nowadays trend of performing phase 0 or translational studies from preclinical phase.

Qualitectrials® has developed clinical research projects with pharmaceuticals, medical devices, OTCs, biological and Biotech products, vaccines, diagnostic products, nutritionals and food supplements, cosmetics, THMPs and homeopathics.

  • Anti infective
  • Cardiovascular
  • Renal
  • CNS
  • Dermatology
  • Endocrinology
  • Gastro intestinal
  • Genitourinary
  • Haematology
  • Immunology
  • Muscleskeletal disorders
  • Oncology
  • Ophthalmology
  • Pain
  • Anesthesia
  • Respiratory
  • Dental
  • Geriatrics
  • Pediatrics
08.
Why Qualitectrials

Our objective is the success of our clients and the research promotion


We are a highly qualified organization


We adapt to the operational and strategic needs of our clients


We are deep knowledge and leaders in our area of expertise


We search alternatives to found the ideal solution


We are deep knowledge and leaders in our area of expertise


Our commitment is the success of the project


We believe in our contribution as an investment and not as a cost

Our commitment
01.

Become a partner better than a service supplier through our deep principle of the win-win strategy

02.

Increase the efficiency of costs. Become a cost effective partner, even better, become an investment instead of a cost

03.

Time reduction through the flexibility of our organization

04.

Quality of delivered projects. Exceeding the compliance with client expectations