Daniela Dorta Email & Phone Number

State Of São Paulo, Brazil

Salvador, Bahia, Brasil

Salvador, Bahia, Brazil

We are the 1st Site Management Organization based in North/Northeast Brazil. Dorta&Cia SMO is a brazilian based organization that functions as SMO/CRO. It was founded in 2016 and since then has successfully managed clinical trials sites in Brazil. We've been conducted + 30 studies phase I-IV clinical trials and device studies offering our services for the sites and Pharmaceutical/CROs Companies. Our mission have been contributed to the stablishment of GCP compliant clinics in Brazil specially in North/Northeast Region.Nowadays our partners are clinical trials site in all therapeutic areas and Pharmaceutical/CROs Companies. We thrive to provide strong partnership for sponsor companies by providing superior clinical trial management services in the Region: ensuring quality care of patients, adherence to local and international regulations/ guidelines and delivery of reliable data.

Salvador Area, Brazil

• Line management, training and coaching of Site personnel; • Resource allocation for the projects; • Feasibility of new clinical study projects under the Business Development prospecitve; • Trial feasibility and viability analysis; • Set up and manage trial budgets; • Manage studies timelines and regulatory tasks; • Oversight of clinical study service vendors; • Oversight of quality of clinical studies (Quality assurance)

Brasil

Responsible to perform Good Clinical Practices (GCP) audits for clients in Brazil and LATAM for Clinical Operations,including system and process of audits, audits of investigator sites and audit at CROs and other services providers.Support the organization in implementation and follow-up of corrective and preventiveactions.Provide business functions with QA and GCP guidanceUnderstand quality by design and further develop our risk-based approach in the auditingprocess.Prepare for and participate in regulatory inspectionsShare best practices and ideas with fellow auditors international level of our clientsConducting more than 50 investigator sites GCP audit for COVID-19 studies, Cardiology, Ophtalmology, Oncology, vaccines and Rare Diseases.

Brazil

Contracted Clinical Oversight Manager Responsible for closely oversee clinical study conduct , management and clinical monitoring activities by the Site Management & CRO accross the assigned clinical study sites to ensure the study is being conducted with high quality according to the protocol, the study team requirements, and in compliance with regulatory, GCP and quality standards. Address and follow up study issues until their final resolution. Clear and appropriate communication among the Sponsor´s Study team and its supplier. Responsible to perform the Sponsor Oversight Visits accompained with CRAs from Contracted CROs. Responsible for a Quality Assurance Consultant for a Leprosy vaccine study and monitoring tasks for Epilepsy’s study with device (3 sites)

Brazil

Being responsible for clinical operation strategy in Latin AmericaWithout a strong working relationship wih clinical trial sites, trial endpoints are difficult to achieve, especially in Latin America.Farmacon’s network of medical and logistical experts tailor solutions to SOLVE clinical research challenges. Our clinical research projects have focused on rare diseases, immune and infectious diseases and pediatric trials.We focus on helping pharmas and biotech to achieve cost and time efficiencies and to meet its study endpoints by tackling REAL “on-the-ground “ issues in the highly challenging Latin-American clinical research space.WHAT WE DO- Tailor solutions needed to reduce overall enrollment timelines- Implement oversight of the clinical research process from Study Start-up to Last Patient Visit to achieve study endpoints- Liaise amongst all clinical trial stakeholders and provide real-time feedback

Recife Area, Brazil

• Provide leadership and oversight for International and National clinical trials;• Supply strategic direction in development and implentation of process changes;• Line management, training and coaching of Site staff personnel; • Resource allocation for the projects;• Feasibility of new clinical study projects under the Business Development prospective; • Trial feasibility and viability analysis;• Set up and manage trial budgets; • Manage studies timelines and regulatory tasks;• Oversight of clinical study service vendors; • Oversight of quality of clinical studies (Quality assurance)

Working with Rare Diseases and Hematology Oncology. Responsible for the planning of project activities, coordinating of the project plan and reporting of progress. Oversees the project until completion and activities include managing a multi disciplinary team. Support in mentoring CRAs on project and department tasks and requirements. Support in conducting quality control accompanied visits with CRAs level 1 and 2.

Salvador Area, Brazil

Salvador Area, Brazil

Salvador

• Function as Lead CRA for global studies, coordinating CRAs, reviewing monitoring reports• Preparation and participation in BID defense meetings with possible customers• Perform feasibility studies (pre-study site selection)• Establishes appropriate standards and quality indicators for site management and monitoring. • Contributes to development and maintenance of the overall Study Management plan. • Conduct all level of monitoring visits in accordance to GCPs and applicable local and international regulations and SOPs. • Provide mentoring and coaching to colleagues and site staff , performing co-monitoring visits and CRAs evaluations• Manage/advise teams in therapeutic areas of proficiency as cardiology• Design monitoring tools • Provide support for the design of CRFs and protocols • Develop monitoring plans, study management plans and communication plans • Actively participate in study team meetings and investigator’s meetings• Conduct training for colleagues or study team • Monitoring experience in US for 3 months • Sites audit preparation and responsible for accompanying auditors during the sponsor audits in the country• Responsible for oversight all process locally as MoH submission, local vendors, importation process.

Direct contact in between WCT Brazil and Brazil MoH . Responsible for DDCM documents, submission and communication with ANVISA.

Conduct all level of monitoring visits in accordance to GCPs and applicable local and international regulations and SOPs. This encompasses clinical trial material (CTM) accountability, regulatory document review and submission (as appropriate), clear and complete trip report writing and site management

• Perform feasibility studies (pre-study site selection) when required• Conduct all level of monitoring visits in accordance to GCPs and applicable local and international regulations and SOPs. This encompasses clinical trial material (CTM) accountability, regulatory document review and submission (as appropriate), clear and complete trip report writing and site management• Ensure completeness, accuracy and submit regulatory and ethical submission documentation as appropriate (e.g. IRB/IC approval, informed consent, lab certification etc.)• Design monitoring tools when requested• Provide support for the design of CRFs and protocols as requested• Develop monitoring plans when required• Actively participate in study team meetings• Actively participate in investigator meetings• Conduct training for colleagues or study team as requested• Manage a cost centre and implement appropriate actions to keep within budget (UK and ROW)

• Responsible for all aspects of study site monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits • Ensure the study staff has received the materials and instructions to safely enter patients into the study • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data • Responsible for all aspects of site/registry management as prescribed in the project plans • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation (endpoints, amendments and safety letters), organization of local meeting and other tasks as instructed by supervisor • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.• Responsible for notifications to regulatory authorities, translation of study-related documentation (amendments and safety letters

• Assistant for Start up team creation and implementation, for improvement of the regulatory terms of the Unit of Clinical Research;• Support to Regulatory Process (responsible for prepare the ethics and regulatory documents and submission documents to Ethics Committees and Regulatory Authorities)• Documents preparation of Financial Agreement/ Contract• Preparation of Master Files, Site Files and Investigator Study Files• Assistant for elaboration of the SOPs, of the sector of Clinical Research regarding regulatory part;• Participation as trainee in cardiovascular and oncology studies.• Responsibilities included assistant clinical trials monitoring, site evaluation and initiation, data collection and auxiliary quality control review of data collected at trial’s sites to ensure compliance with multiple international and local protocols, FDA/EMEA regulations, Brazilian regulations and GCP/ICH guidelines for Phase IIIa,IIIb and IV trials.

Phd, Biotecnologia Em Saúde E Medicina Investigativa

Specialist, Principles And Practice Of Clinical Research

Specialist, Xi Curso De Introducción A La Ética De La Investigación En Seres Humanos, Specialist

Master Of Business Administration (Mba), Project Management

Specialist, Pharmaceutical Medicine

Specialist, Biochemistry And Molecular Biology

English

Bachelor Of Pharmacy - Bpharm, Pharmacy