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Doctor Delia Oros

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CRO Services

HUMANAMED CLINICAL TRIAL CONTRACT RESEARCH SERVICES (HCTCRS)

“Your Number 1 Partner for Clinical Trials Services for Medicines and Devices in Romania”

We understand challenges confronting our clients on the long journey through clinical development !

Organisation Profile

Humanamed Clinical Trial Contract Research Services is a full service clinical service Contract Research Organisation (CRO) offering reliable high quality clinical trial services to clients across all medical fields for both pharmacological and device therapies.

Humanamed the parent company of Humanamed Clinical Trial Contract Research Services for over 12 years has been at the forefront of providing high quality healthcare in Romania through its fully equipped privately owned medical diagnostic laboratory and dedicated technical team.

Another company under the Humanamed group of companies is Professional Medical Service PMS a supplierof laboratory reagents in Romania.

Located in the eastern Romanian city of Oradea that is quickly accessible from All Over Europe through Budapest, Debrecen or Cluj Napoca Airports Humanamed Clinical Trial Contract Research Services is supported by a team of experienced pharma professionals and clinicians,   a first class in-house approved  fully equipped medical laboratory and access to over  10 hospitals and polyclinics with high patient numbers.

Our effective project management system is supported by a Clinical data management system utilizing regulations complaint reliable software that provides our clients with a first class clinical data management service that includes double data entry, audit trails, query management and reporting.

Our  Clinical Trial Medical Services for Medicines and Devices

We conduct clinical trial feasibility studies to provide you with information regarding:

  • Research environment and infrastructure
  • Regulatory, medical and regional requirements
  • Local regulatory and ethics review timelines
  • Compatibility of the protocol and assessments with current standard of care
  • Potential modifications to clinical trial design and eligibility criteria to enhance enrollment and execution
  • Competing clinical trials
  • Availability of the targeted patient population
  • Investigator interest in the clinical trial concept.
  • Site capabilitie, Personnel, Equipment and Contractual requirements
  • Projected patient enrollment rates

Clinical Trial Implementation Services

We have experience in clinical research and a good understanding of the medical requirements to conduct clinical trials in Europe. Our clinical professionals have trial experience in oncology, neurology, psychiatry, dermatology and cardiology. All our sites are located in large well equipped hospitals and polyclinics.

  • Protocol development
  • Site Selection and management
  • Investigator recruitment
  • Patient recruitment
  • Medical support of project teams
  • Medical review of coding
  • Ongoing safety review
  • 24/7 medical support
  • Medical review of clinical study reports
  • Medical expert opinion
  • Consultancy services
  • Organizing local advisory boards

Clinical Trial Administration

We can provide you with ICH-GCP  CTA compliant clinical trial services which include the following services:

  • Co-ordination of meetings required for the purposes of the study
  • Co-ordination of ethics and regulatory applications
  • Design and establish the Trial Master File (TMF) framework
  • Collection, maintenance and tracking of Essential Documents within the TMF
  • Blinded and unblinded TMFs, maintained by separate teams with separate facilities
  • Coordination of correspondence; your own TMF email account(s)
  • Establishing Investigator Site Files (ISFs) for distribution to site
  • Maintaining and updating ISFs with all relevant documentation
  • Essential Document Checklists, for both TMF and ISFs, produced regularly for your review
  • Tracking of documentation development and distribution
  • Distribution of documents based on your requirements
  • Appropriate printing and fireproof storage facilities
  • Paper and/or electronic documentation produced for archiving
  • Co-ordination of archiving

Medical Device Clinical Research Service

We assist clients provide proof that their devices comply with the required efficacy and safety European standards that eliminate unwarranted risks to patients. Conducting device medical research at our hospital sites with unprecedented high patient numbers, we shall lead you to the European device market in a short time by providing evidence of product superiority.

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Protocol Designs

All phases (in-vivo, in-vitro, first-in-human, and large population trials)

Protocol revisions

Subject stratification for enrollment

Submission for regulatory approval

Case report form (CRF) and instruction booklet design translations

Trial Implementation

Presentations to IRB/Ethical Review Committee

Site and investigator selection

Site management and clinical monitoring

Device training support

Technical documentation

Compliant data management

Medical device import/export

Study Results

Report and analysis

Medical statistics

Medical narrative writing

Pharmacovigilance

Humanamed Clinical Trial Contract Research Services provides Pharmacovigilance and Risk Management (PVRM) services for all study phases ensuring compliance with the highest current drug safety standards at all times.

Activities can include:

  • Protocol review and PV activities, including subject safety
  • Collating, reviewing and reporting Adverse Events (AEs)
  • Periodic reporting of collated AEs
  • Writing and submitting safety updates to ethical and regulatory authorities
  • Expedited reporting of suspected unexpected serious adverse reactions (SUSARs)
  • Writing and reviewing PV sections of study reports
  • Provide a seamless approach to drug safety for products undergoing both clinical and post-marketing assessments through;
  • Signal Management ( Monitoring, Validation, Analysis and Prioritisation, Assessment)
  • Aggregate and single ICSR Processing ( Screening, Initial ssessment and Validation)
  • Checking MedDRA and WHO-DRL/DD Coding
  • Literature Review
  • Narrative Writing
  • Laboratory and Diagnostic test Reviews
  • Expert Medical Reviews
  • Identifying and Coordinating with Experienced Physicians
  • SAE Followup Activities

Regulatory Affairs Service

On flexible case by case basis we offer the following regulatory services:

  • Regulatory strategy development
  • Clinical, non-clinical and CMC expertise
  • Preparation and submission of CTAs/INDs for phases I-IV
  • Regulatory agency liaison including meeting preparation and facilitation
  • Marketing authorisation applications
  • Ethics committee submissions

Contacts:

Humanamed Clinical Trial Contract Research Services

Oradea,Tudor Vladimirescu street,Nr.8

Bihor County,Romania

Tel:0040359435427

office@humanamed.ro

hctcrs@humanamed.ro

www.humanamed.ro