Clinical Development Services
The foundation for excellence in clinical research
Whether you are in need of one or more specific capabilities or seeking a strategic functional service provider (FSP) partnership, we can help.
Across a full range of clinical development services, we offer the deep expertise, operational excellence and advanced technologies you need to navigate the complexities of today’s clinical trial environment.
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Biostatistics & Statistical Programming Services
Whether it’s a small first-in-human exploration or an international clinical trial, our global Biostatistics and Clinical Programming services team brings technical expertise and efficiencies to projects of all sizes, through all phases of clinical development and commercialization.
Accuracy when it counts – which means always
Our standardized processes, validated technologies and experienced staff prepare tables, figures and listing outputs in advance of database lock, helping you make swift internal decisions and communicate effectively with the public, partners and/or investors.
Offering analysis and reporting services to meet every need, including:
- Consultation statistique de pointe
- Plans complets pour les analyses statistiques
- Calendriers de randomisation produits conformément aux exigences de la technologie de réponse interactive
- Ensembles de données et métadonnées prêts à être présentés, conformes aux normes et tendances du secteur
- Tableaux, listes et figures à l’insu ou sans insu (par exemple, analyses intermédiaires et comités de contrôle des données), rapports statistiques autonomes.
Clinical Data Management Services
Combining the latest technologies with years of data management experience, our global Clinical Data Management services team adopts an intelligent approach to developing and implementing quality data collection solutions. With a focus on a streamlined, effective route to database lock, we utilize a suite of techniques to identify and resolve data discrepancies and assure data quality.
We strive for real time readiness and believe in data transparency
We use novel approaches and tools to monitor and report on data quality and progress and keep our customers up to date with performance throughout the project. Quality and risk management are embedded are every step to facilitate early risk/issue detection, feed vital information to the project team and provide an adaptive approach to monitoring and trial delivery.
Industry-leading EDC solutions and technology innovation
We specialize in customized solutions to accommodate project-based or flexible functional service provider models. Nos équipes maîtrisent tous les systèmes de base de données cliniques les plus performants de l’industrie, et nous réalisons des études de saisie électronique des données depuis plus de 15 ans, avec plus de 1 700 études achevées ou en cours.
Clinical Monitoring Services
A clinical trial has many complex, moving parts and each must be monitored to protect the safety of study participants and data integrity while keeping the study running according to protocol and regulatory requirements.
Streamlining strategy to mitigate risks and drive data integrity in clinical trial monitoring
We take a risked-based monitoring (RBM) approach to developing and executing monitoring strategy, using comprehensive dashboards customized to the specific risks of each trial.
Orchestrated by the clinical trial manager, our highly-skilled central monitors (CTs) and clinical research associates (CRAs) collaborate closely and work in sync along with our risk managers and RBM subject matter experts to resolve concerns swiftly so that patients stay safe, studies stay on schedule and results remain robust.
Et qu’est-ce que cela donne?
• Issues are detected 20% faster than by traditional monitoring methods
• 40% of queries and protocol deviations are detected by our CMs so that CRAs can focus on taking corrective actions with sites
Developing new clinical talent
Our Clinical Monitoring team members perform crucial roles in patient safety, site and study compliance and clinical data integrity. La composition du personnel et la constance sont primordiales pour assurer la réussite du projet. Our Clinical Training Institute and Oncology Academy, accredited by the International Accrediting Organization for Clinical Research (IAOCR) helps us maintain a talent pool of CRAs focused on high-quality project delivery. We’re building better CRA teams with first-in-industry immersive virtual workforce training.
Medical Writing Services
Notre expertise de classe mondiale en rédaction médicale couvre un large éventail de domaines thérapeutiques et de types de documents, de la déclaration préclinique tout au long du continuum du développement de médicaments, en passant par la rédaction pendant et après la commercialisation. Nos services comprennent :
- Protocoles et modifications
- Dossiers de produits médicinaux expérimentaux (DPME)
- Formulaires de consentement éclairé et dépliants d’information pour les patients
- Rapports d’études cliniques (complets, abrégés, provisoires et synoptiques)
- Exposés sur l’innocuité au niveau des patients et des événements
- Rapports annuels
- Documents de directives
- Brochures pour les chercheurs
- Dossiers de présentations de nouveaux médicaments de recherche (PNMR), présentations de nouveaux médicaments (PNM) et dossiers de document technique commun (CTD)
- Réponses réglementaires
- Profils de risque
- Rapports périodiques actualisés de pharmacovigilance (PSUR)
- Rapports périodiques d’évaluation des avantages et des risques (RPEAR)
- Listes sommaires périodiques de la Food and Drug Administration des États-Unis
- Plans de gestion des risques (PGR)
- Rapports de mises à jour périodiques sur la pharmacovigilance relative aux produits en développement (RPP-D)
- Sommaires locaux de l’innocuité des médicaments (LSS)
- Analyses de signaux
- Aperçus cliniques
- Rédaction de publications médicales
- Aide à la planification et à la soumission des articles à publier
- Revues et recherches de la littérature
- Présentations orales, affiches et résumés
- Ensemble de diapositives
- Lettres d’information médicale
- Créer des diapositives pour le comité consultatif
- Soutenir les présentations
- Gestion des projets de documents
- Finaliser et publier le document réglementaire
- Transparence et divulgation des essais cliniques
- Documents en langage non scientifique
- Rédaction de documents
- Soutien aux dossiers des registres de l’essai clinique
- Bibliographies des présentations réglementaires
Exploitation du dossier principal de l’essai
Les essais cliniques peuvent être de grande envergure et complexes, faisant intervenir de nombreux services et partenaires. Par conséquent, la gestion du dossier principal de l’essai clinique (TMF) peut devenir une tâche difficile. We are a specialist provider of technology-enabled eTMF solutions and other support services for the global clinical research market.
Our skilled, dedicated team manages the TMF process with a focus on quality and compliance, and we’re here to help ensure success for your trial. Le traitement rapide, complet et précis des documents TMF est l’un des services les plus importants que nous fournissons. Nos services comprennent :
- TMF completeness reviews
- TMF inspection readiness evaluations
- TMF migration planning/remediation
- TMF transition/conversion
- TMF consultancy services
- Document processing services
- TMF management services
Rater Training Services
Nos spécialistes de la formation des évaluateurs travaillent à améliorer la qualité et l’uniformité de l’administration et de la notation des tests/de l’évaluation comportementale des échelles afin que nos clients puissent constater une amélioration de la qualité et de la cohérence de leurs données.
Our team members are highly experienced clinical psychologists, neuropsychologists, psychometrists and assessment specialists who have extensive global experience in providing rater training. They provide expert, comprehensive rater evaluation, rater training and rater scales management services coupled with unparalleled scientific, technical and procedural support.
Considérez-nous comme la source définitive de formation des évaluateurs, des évaluations faites par les évaluateurs (vérification centralisée des évaluations), de la gestion des documents (traductions, harmonisation, droits d’auteur, carnets de travail) et de l’évaluation neuropsychologique informatisée dans les essais cliniques multicentriques.
Clinical Trial Investigator Management Services
We are dedicated to ensuring our customers obtain the quality clinical research data they need to get medical treatments to patients sooner. To do this it’s essential that clinical trial principal investigators and sites are happy with the clinical trial payment process and we achieve this through automation, industry-leading transparency reporting capabilities, and integrated data management and site contracting. We remove pain points by:
- Assigning a dedicated, single point of contact at the CRO or sponsor to handle financial matters
- Communicating the payment escalation process at the beginning of each study
- Making sure sites receive monthly clinical trial payment
- Making the process simple, fast, transparent and efficient through use of our proprietary online tool
- Providing top-line simultaneous notification of payments received and pending for speedier and more efficient reconciliation
- Reducing the number of invoices that sites are required to generate and removing holdback clauses wherever possible
Learn more about what we offer and how we partner.
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