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Clinical Research Services

Clinical Research Services
It is our people that make the difference!

In our first successful 15 years in business, BioClever has gained significant expertise in both pre-approval and post-approval trials. Our proven service portfolio ensures that we can provide you with custom solutions to assist with patient recruitment on time and on budget

BioClever CRO offers a full range of clinical trial research services and support in the areas of pharmaceutical and medical device development.

Better than any other Contract Clinical Research Organization and Development Resource, BioClever approaches and responds to clinical R&D and regulatory issues by applying our broad know-how and solutions portfolio.

From early R&D clinical development and regulatory activities through late-phase clinical trials, BioClever offers a full range of integrated product development services. Regardless of your point of entry, BioClever will design a customized clinical and regulatory program providing seamless access to our full range of development services, based on your specific needs.

Clinical Research Services:

Clinical Trial Design and Start-Up

BioClever has ample experience in a wide range of clinical trial designs, including:

  • Open-label
  • Blinded (single or double)
  • Randomized
  • Parallel-group
  • Cross-over
  • Placebo-controlled and/or comparator

Share your clinical trial idea with us and we will develop a concept sheet proposal.

Project Management

At BioClever, all our staff come from the clinical research industry. They have wide experience in management and consultancy methodologies, and offer our clients quality services that will deliver projects on time and on budget. Projects are thoroughly followed up to completion, and any potential risks are minimized as far as possible.

Clinical Monitoring

Our CRAs are experienced in working effectively with sites to ensure that patient recruitment and study milestones are met.

Our annual staff turnover is low (less than 5%) and our employee satisfaction rate is high (90% of our people are happy and feel valued in their job*), so we can assure our clients that the same CRAs who start up a trial will be there at close-out.

Data Management and EDC

Our team of professionals is prepared to perform all the tasks required to conduct a quality clinical trial. They will design the CRF or eCRF, create and validate the database, manage and code all AEs and SAEs, and process and enter fully-coded data according to international dictionaries.

Ennov’s Clinical software suite provides sponsors, investigators and patients with a comprehensive, end-to-end solution for the collection and management of all clinical trial data, whether structured or unstructured, from the earliest stages of planning through study conduct and close-out. The Ennov Clinical suite includes Clinical Data Management applications (Ennov EDC, Ennov RTSM and EnnovePRO) and Clinical Trial Management applications (Ennov CTMS and Ennov eTMF) that are available to use on the cloud or on-site. 

Statistics

All our studies are conducted according to standard operating procedures that comply with ICH guidelines E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports). These procedures are implemented at all stages of the process, including protocol writing, statistical analytical planning (randomization, sample size calculation, etc.), statistical programming (reports and statistical analyses), and providing statistical consultancy to the medical community.

Data Standardization

CDISC is the standard system for submitting clinical data to regulatory agencies.  As a member of the CDISC organization, BioClever receives constant updates on SDTM implementation guidelines and ADaM development datasets

Medical and Scientific Writing

Our medical writing team is fully involved in R&D design, clinical writing, medical monitoring and biostatistics.

All processes involving clinical trial reporting are conducted according to the ICH:E3 guideline (Structure and Content of Clinical Study Reports), which ensures trustworthy and quality results for our clients.

  • BioClever Barcelona
  • Rambla Catalunya, 135, 3º 1ª, 08008 Barcelona
  • 934086388
  • info@bioclever.com
  • BioClever Madrid
  • Ronda de Poniente, 10 28760 Tres Cantos - Madrid
  • 910888877
  • info@bioclever.com