Services
We offer a wide range of services at Research Professionals, a regional Clinical Research Organization (CRO). We provide you with access to excellent study sites, and experience with hundreds of patients recruited in 15+ therapy areas. Research Professionals bounds up with 150 associated staff – including nurses who are fully dedicated to the highest standards of conducting clinical trials in Central and Eastern Europe. The combination of local knowledge, global experience, and the latest technology allows our clients to conduct their studies faster and more cost-effective.
We provide easy access to the best specialists' sites in the region
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Sponsor company size
- Startup/ Spinoff
- Small and medium sized
- Large sized
Location of clinical study
- Hungary
- Central and Eastern Europe
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Clinical Services
Trial Management
We plan and implement clinical trials and deliver them on time – to budget and objectives that conforms with all aspects of trials and the relevant standards. When we lead your project, our main concern is to release you from any stress related to the project management. We initiate and manage the project team for your trial, and we coordinate communication between all parties.
Our clinical project manager will lead your clinical study by
- Achieving study objectives by working with team members to set project priorities and milestones, and resolving project conflicts
- Maintaining professional expertise through acquaintance with therapeutic area and clinical research literature
- Managing clinical projects from concept through clinical study report completion
- Assessing the operational suitability of studies and recommending execution and risk mitigation plans
- Developing and tracking study timelines, budget, and quality metrics
- Ensuring that appropriate clinical resources are available for the clinical project
- Leading the development of study-related documents, including study protocols, informed consent documents, study manuals, and plans, investigator site files, case report forms, design, etc.
- Overseeing clinical research study conduct
- Organizing and leading the clinical project team; leading regularly scheduled cross-functional study team meetings with internal and external resources
- Helping with the training and development of all clinical staff members
- Participating in meetings with investigative sites, key opinion leaders, and consultants as needed
- Playing a part in the analysis, summary, and reporting of clinical data through the course of the study
- Evaluating monitoring reports with significant findings to confirm appropriate conclusions and actions are taken
- Reviewing serious adverse events, and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks
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Regulatory Management
We manage regulatory submission activities for assigned clinical trials (Phase 1 - 4 and Medical Device studies). We have vast experience in regulatory submission, and we are responsible for the execution of the submissions, as well as the quality, and completeness of the regulatory proposals for clinical trials.
Our regulatory managers are responsible for
- Planning, undertaking and overseeing regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Liaising and negotiating with regulatory authorities
- Preparing submission packages to regulatory authorities and ethics committees
- Harmonizing study documentation with local requirements
- Outlining requirements for labeling, storing, and packaging
- Writing comprehensible, user-friendly, clear product information leaflets and labels
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Feasibility / Landscaping
We deliver excellent sites with the best Principal Investigators. We evaluate clinical trials awarded by Sponsors to determine whether they are an appropriate fit for exceptional performance. The process includes assessment of operational capabilities, trial budgets, and resources needed.
Our feasibility process includes
- Studying lead review and suitability assessment for placement at various sites
- Designing Feasibility Questionnaires (FQs) focused on the site's capability to successfully conduct the study
- Coordinating and supporting the sites in the completion of FQs within the requested timelines
- Coordinating Site Qualification Visits to evaluate the site's ability to carry out the study protocol, and enroll a sufficient number of patients
- Coordinating in-depth reviews to ensure the site has the patients, and PI approves of the protocol
- Scheduling Feasibility Meetings to evaluate the collected feasibility data
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Vendor Management
Vendors are critical to the successful outcome of your clinical study however you do not need to retain the ultimate responsibility for the outsourced activities. You can rest assured that study activities delegated to our vendor manager and we will take measures to ensure any subcontractors are consistently delivering products or services of acceptable quality.
Our vendor managers will completely control your external suppliers by
- Participating in vendor selection, negotiation and management, including monitoring of associated budgets and contracts
- Reviewing and approving invoices from study vendors, investigators, consultants, etc.
- Responding promptly and appropriately to study questions and issues raised by vendors and consultants
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Site Budget and Contract Management
We keep strong relationships with the best specialists and eliminate time-consuming site negotiations to keep your study on track for a prompt start. We use standardized contract templates including both legal and financial terms to reach agr​eement with your sites.
Our contract managers are ready for
- Submitting investigator budget for site review
- Creating and reviewing site-specific budgets, contracts, and associated documents
- Administering all contract management processes, including coordination with relevant protocols, ICF, departments, investigators and subcontractor
- Working within the predicted contracting timelines
- Observing basic financial aspects of the project
- Cooperating with internal and external legal, financial, and clinical operations departments
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Clinical Trial Monitoring
When we monitor your clinical study, we place increased emphasis on critical data and processes to improve the efficiency, and effectiveness of the clinical oversight as measured on various quality, timeline, and cost dimensions. Our Clinical Research Associates keep a close eye on your study aiming safeguarding subject safety, data quality, and protocol compliance by focusing on sponsor oversight on the most important aspects of the study conduct.
All of our CRAs have a meticulous approach on
- Good understanding of ICH-GCP and Medical Device regulations that ensure good clinical practice and regulatory compliance is maintained
- Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site
- Liaising with doctors/consultants or investigators on conducting the trial
- Setting up the trial sites, which includes ensuring each center has the trial materials – including the trial drug often known as the investigational medicinal product
- Training the study staff in the standard operating procedure for the clinical trials as per applicable regulatory requirements
- Verifying that the investigator and the investigator's team are adequately trained and comply with the protocol
- Monitoring the trial throughout specified duration, involving monitoring visits to the trial sites
- Verification, evaluation of the conformity of the data presented in case report forms with source data
- Reviewing informed consent forms, case report forms, investigational drug accountability, and adverse events
- Ensuring all unused trial supplies are accounted for
- Writing visit reports, filing, and collecting trial documentation and reports
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Home Care Research Nursing
If patient comfort and convenience is a must in your clinical study, we are the best choice. We bring the site visit to patients wherever they live, work, study or play. Our processes ensure the confidentiality of subjects' identities. In-home nursing is led by a physician and a matron with clinical trial experience to deliver the highest standards in off-site clinical study visits.
Our home care services include
- Selection and screening of Research Nurses
- Checking qualification/professional registration, and then contracting the Research Nurse
- Designing source documentation for home care activities
- Coordinating general, and study specific trainings for Research Nurses
- Attending site introductory meetings and providing site trainings
- Managing off-site visits and researching nursing activities
- Providing visit-related equipment for Research Nurses
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Patient Travel Expense Reimbursement
All subjects participating in clinical trials shall be reimbursed for their confirmed costs. To manage this expense reimbursement, sponsors must comply with ethical, taxation, legal, and data privacy requirements. This solution is the perfect choice to face these challenges.
The system is capable of
- Reimbursing all confirmed expenses related to study visits to the extent and timelines as agreed with Sponsor
- Considering all taxation aspects of subject travel reimbursement
- Liaising directly with the subject to ensure all reimbursements are received
- Handling subject personal data according to the current regulation
- Submitting adequately anonymized reports for the Sponsor
- Performing GDPR compliant data protection oversight by an appointed Data Protection Officer
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Global Full CRO Service
We offer a full range of services by ACROSS Global, a strategic alliance of clinical research organizations (CROs). Our members across 95 countries provide you with access to 7,550+ study sites, and experience with 127,000+ patients recruited in 25+ therapy areas. The 1,600+ employees of ACROSS are fully dedicated to the highest standards of conducting cost-effective clinical trials across the globe. The well-balanced combination of local knowledge, globally experienced professionals, and the latest technology allows our clients to conduct faster, cost-effective studies without sacrificing quality. Whether for small or mid-size Pharma, Biotech and MedDev, the ACROSS Global Alliance makes global studies seamless.
We provide full service clinical operations
- Selecting and managing the Central Lab
- Developing Clinical Study Reports
- Designing drug labels
- Developing, reviewing, and adapting Informed Consent Form (ICF)
- Organizing Investigator meeting
- Institutional Review Board (IRB) submission
- Translating and adapting legal documentations
- Monitoring Plan Development
- Obtaining local insurance
- Budgeting and planning the project
- Project Status Update Report
- Developing and finalizing diaries
- Reviewing and finalizing questionnaires
- RA/CIRB Initial Submission and Protocol Amendment Submission
- Processing Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR)
- Site Management (site identification and selection, qualification visits, documents collection, initiation visits, monitoring visits, close-out visits, payment processing)
- Training Sponsor SOP
- Selecting and managing the Study Depot
- Preparing study materials
- Training study teams
- Vendors Selection and Management
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Human Services
Executive Search and Recruitment
Why don't you hire the most qualified person? We can find a candidate with a rare mix of skills. Our self-developed platform will save time and resources to find the most needed member of your future staff. We understand your goals, culture, plans, and vision, which helps us to serve you with the candidates who are the ideal fit for the company.
Features of the platform
- Corporate culture assessment for core mission and values, corporate image, leadership structure, interpersonal relations, team engagement and communication style, employee retention and office environment
- CV verification and pre-employment check to confirm the veracity of the candidate's qualifications, work history, right to work in the country and criminal record
- Aptitude and personality test to assess the performance of candidates of which the cornerstones are willingness, emotional and social skills
- Skill development represents an investment in your team and retains and develops employees to the overall benefit of the business
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HR Outsourcing
Let your company focus on its core business and save money by reducing HR operating expenses. You can make up for the lack of in-house expertise and sub-contract human resources functions to us. We manage the hiring, payrolling, administration of health benefits plans, retirement plans, and workers’ insurance, training, and legal expertise.
We serve your company by
- Providing human resource services for the conduct of clinical research studies
- Performing with a high standard of proficiency, in a timely manner, and in accordance with the requirements detailed in client's Code of Ethics and requirement list
- Undertaking to comply with the prevailing laws, decrees, as well as the provisions of Codes of Ethics and professional rules