Result for tag: "regulatory affairs strategy"
Phase I – III
TFS offers a full suite of clinical services and functional solutions on a global, regional, and local basis. Our global reach, focused therapeutic experience, client-centric approach, and robust tech...
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sae risk mitigation regulatory writing csv study close out outsourcing solutions fsp cro ophthalmology product development retinal dystrophy irritable bowel syndrome itchy skin toxicity cell immunotherapy inherited retinal disease vaccine gastric aiom/siapec certification ophthalmic clinical development acute coronary syndrome customer global cro rwe cro midsize cro drug safety and pharmacovigilance right people right solutions gi clinical development proactive approach to clinical trials tfs world renowned professionals list of clinical trials work for our customers phase one product development drug drug interaction orphan indication observational wearable flexible global structure cra pharmacovigilance icsr benefit-risk medical communication qms documents resolve study issue workforce solutions expert cross functional hemato-oncology team that can you bring your life saving compound faster to the market through flexible tailored solutions for different complex hemato-oncology study designs ophthalmic clinical research solutions retinal degeneration infectious disease protein therapy safety advanced therapy medicinal product masking procedures bird flu breast rcc internal medicine cro cholesterol offering top mid-size cro real world evidence cro early phase planning statistics therapeutic experts respiratory clinical development adapt to needs tfs examples of work physician for clinical trial diversify your experience phase 1 therapeutic experience food drug interaction medical devices non-interventional hru minimize cost line manager postmarketing pv evweb adverse event emwa legal clinical trial expert fit for purpose rigorous oversight & proactive project management to ensure successful execution ophthalmology study design macular edema secondary to crvo men’s health dystrophic epidermolysis bullosa regulatory atmp feasibility investigator meeting tumors tki internal medicine clinical development atrial fibrillation partner cro for biotech biotech product development regulatory strategy medical writing therapeutic clinical development neurology clinical development educate and reduce risk tfs expert consultants clinical research forward thinking organization phase i study strategy flexible trial design pivotal studies prospective post-marketing ensure success monitoring post-approval pv local qppv adverse drug reaction protocol quality issues protection of human subjects outsourcing established kol and site network ophthalmology study protocol alzheimer’s disease transplant deb diabetes infrastructure and water site start-up alliance for multispecialty research unresectable complete survival collection cv clinical development diabetic nephropathy resourcing cro for flexible resourcing functional service provider clinical operations medical monitoring hemato oncology cns clinical development aligned to face the crisis tfs partner experts motivated by results boost your career phase two clinical trial development adaptive design pivotal 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patient experience color fundus photography investigator identification refractory advanced solid tumors proactive planning gi neuroscience cro in-house care clinical development services strategic resourcing phase 4 project management oncology clinical trials rare diseases managing through the crisis tfs groundbreaking discoveries bring solutions to market faster the tfs advantage phase ii clinical trial submission umbrella trial drugs retrospective ehealth quality and delivery co-monitorings qppv drug safety physician reliable data manuscript risk-based audits safety accountability clinical services outsourcing engaged and motivated leadership team as well as the project teams with a partnerhsip minded approach and customer centric focus. macular degradation parkinson’s disease cystic fibrosis fragile skin c-peptide patient engagement visual field test emetogenic chemotherapy maximum tolerated dose ocular disorders endocrinology neuroscience clinical development nursing healthscience strategic insourcing phase four resourcing solutions oncology clinical development orphan drug development seamless collaboration tfs innovations open minded professionals join a global company phase three clinical trial approval biosimilarity biologics database digital health project tracking project delivery gvp periodic reports robust procedures clinical evaluation report medical monitor assurance of gcp global outsourcing solutions dermatology trial retinopathy stroke veeva patient reported outcomes mixed meal tolerance test site engagement sd-optical coherence tomography chemotherapy-induced nausea and vomiting progressive multifocal leukoencephalopathy retinal disease metabolic pain clinical development health science workforce management rwe study recruitment services dermatology pediatric clinical development tfs healthscience insights tfs expert opinions team players multidisciplinary assignments phase iii study conduct bioequivalence devices pragmatic virtual studies expert data collection site level good pharmacovigilance practices safety management plan proficient teams abstract medical safety monitoring assure quality managed team full service cro retinopathies traumatic brain injury clinical suite registry metabolic disorders high screen failure multifocal electroretinography cinv pml data management and biostatistics respiratory analgesia life science phasei-iv outcomes trial individual resourcing immunology rwe tfs health science insights tfs results grow your professional role helpful teammates phase 3 protocol development pet imaging therapeutic development phase iv questionnaire project sop local level literature searching sdea preferred edc systems and in-house database programmers poster medical expertise senior study oversight contract teams atopic dermatitis trial