Result for tag: "Risk-based audits"
Quality and Compliance
TFS HealthScience operates Quality and Compliance as an independent unit reporting directly to the CEO. The team is dedicated and vigilant so customers can rest assured that their clinical trials, pro...
hematology cro pragmatic phase 4 trials functional services provider fully managed teams internal medicine expertise current covid-19 studies tfs articles potential clinical site team environment working with experts phase iia micro dosing pk/pd clinical trial management system cohort partnership with customers clinical project plan principal investigator psur audit readiness ecoa internal tools quality study report review clinical trial guidance contracted clinical development prurigo nodularis trial corneal disorder insomnia genetic engineering immuno-oncology geriatric genetic engineering unit site activation colorectal monitoring rules rare disease nephrology sleep hemato-oncology cro virtual trials fsp flexible staffing investigator sites continuity of business tfs library of articles clinical trial registration family environment career assistance phase iib single ascending dose regulatory affairs strategy clinical data platform epro relationship of trust project communication study coordinator rmp inspection readiness expert biostatisticians gcp protocol design review assess inclusion exclusion contracted workforce clinical trial in dermatology diabetic macular oedema type 1 diabetes small molecule inhibitors i-o visual acuity genetically modified bacteria oct technician nsclc gastrointestinal symptoms real time edc urology connect clinical trials dermatology cro virtual clinical development fsp model end to end global clinical development men's and women's health studies mobilized resources and capabilities tfs resources involvment in clinical studies appreciated specialists challenging projects early phase unit sad bioanalytical virtual study pro quality performance study documentation site staff expedited reporting audit topline results audits site team interaction 24/7 study questions answers contracted cro dermatology study ocular inflammation colitis chronic skin disease biomarkers sd-oct fee negotiation european strategic action program ovarian flushing relationsheep women’s health network mid-size cro ophthamology cro tailored solutions regulatory and study start up outsourcing model cardiovascular clinical development flexible solutions tfs key opinion leaders planned clinical trial in immense job satisfaction grow together as a team clinical development journey mad pediatric virtual clinical trial coa adherence to timelines manage project closeout centralized monitoring xevmpd inspection cdisc mapping sops study design functional services cro outsourcing ophthalmology cro retinal vein occlusion crohn’s disease inflammed skin ethics tcr-t intravenous injection healthy volunteer pancreatic dsmb expert cro hypertension expert european cro neurology cro clinical development clinical monitoring solutions driven professionals delivering quality gastrointestinal clinical development new reality tfs kols database of clinical trials collaborative environment early phase product approval multiple ascending dose elderly rwd ecoa on time and on budget site management drug safety 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 study pass late-phase project lifecycle remote monitoring clinical safety eu qppv serious adverse event clinical study report capa assure rights of human subjects functional outsourcing preferred provider hemato-oncology focused lab and imaging vendors ophthalmic research trial cognitive impairment asthma skin disorder patient recruitment protocol design neurodegeneration amr relapsed database lock gastrointestinal type one diabetes nurse contract research organization fsp outsourcing post authorization quality and compliance hematology clinical development psychiatry clinical development safety of our patients tfs latest trends driven by passion family atmosphere phase 2 device development basket trial pivotal trial paes mhealth team building on-site monitoring risk management automation susar single service medical writing compliance assure patient safety functional services outsourcing a highly committed age related macular degeneration epilepsy copd blistered skin patient retention 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