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

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

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

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

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

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

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

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

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

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

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