HarmonyCR has a reputation for expertise in developing flexible and customized solutions to meet client’s needs
HarmonyCR supports clients from protocol through Clinical Study Report writing. Medical writing services include development of the protocol, Investigational Medicinal Product Dossier, Investigator Brochure, as well as writing of other trial and participant documents in accordance with local requirements (including ICF, participant ID card, diary, user manuals, and instructions). We also offer translation of applicable documents in the local language(s).
The regulatory framework is a critically important aspect for any clinical trial. HarmonyCR can take care of contract negotiations with sites, collection of essential documents, and preparation and submission of the documents needed to obtain the required regulatory approvals. To ensure a smooth trajectory during clinical trial conduct, we also ensure full life-cycle maintenance of clinical trial authorizations in compliance with regulatory requirements.
The Project Manager’s (PM) role cannot be underestimated, as (s)he is to a clinical trial what a conductor is to an orchestra. Following a risk-based approach, HarmonyCR ensures seamless project management services. We always ensure that a clear responsibility and communication structure is defined upfront. A deliberate Project Plan is the ‘foundation’ of a clinical trial, ensuring a smooth start-up and efficient conduct of the trial. HarmonyCR’s PM coordinates the study team (internal and external members) and provides the client with all necessary tools to keep oversight of the trial.
From site selection through site initiation, monitoring, and close-out, HarmonyCR is well versed in all clinical monitoring aspects (both remote and on-site), applying a risk-based approach. We keep in close contact and maintain very good relationships with investigational sites, and attach great importance to proper and up-to-date trial documentation and filing. At HarmonyCR, we can also install independent teams for blinded and unblinded visits.
HarmonyCR uses the Viedoc eCRF system, which also includes modules for eDiary and ePRO, and offers the possibility to use video calls for remote visits. All modules are compliant with smartphone, tablet, and computer. Data management activities comprise CRF development, writing of the Data Management Plan, Data Validation Plan, and CRF completion guidelines, setting up and maintaining the clinical database, uploading or reconciling external data, medical coding according to MedDRA and WHOdrug, data cleaning, SAE reconciliation, data review meeting, and database lock.
Statistical services that HarmonyCR provides to its clients include sample size and power calculation, writing of the Statistical Analysis Plan, creation of randomization list and/or code envelopes, creation of data review listings and tables, programming, generation of tables, listings and figures, statistical analyses, writing of statistical reports, and statistical review of the Clinical Study Report. If requested, CDISC conversion of data (SDTM and ADaM) can be performed, including specification document, define.XML, and data reviewer’s guide.
Pharmacovigilance services that are provided by HarmonyCR include writing of the Safety Management Plan, (support in) sponsor and product registration in Eudravigilance CTM, development and maintenance of the safety database (Excel or a validated system), SAE receipt, processing and reconciliation, development and reporting of SUSARs (CIOMS/Medwatch forms) to regulatory authorities, and Annual Safety Report writing and reporting.
Along with medical review of trial and participant documents (e.g. protocol, ICF), and writing of the Medical Monitoring Plan, HarmonyCR’s Medical Monitor also provides medical training (e.g. on therapeutic area, protocol) and support to the project team for medical questions. He/she supports the Investigator and study staff regarding safety questions and medical emergencies. The Medical Monitor performs medical review of trial, lab and safety data, protocol deviation listings, tables, listings and figures, and the Clinical Study Report. The Medical Monitor is also closely involved in all that relates to Data Safety Monitoring Board meetings and dose escalations.