Skip to content
Precision for Medicine
Contact
Upcoming Webinar

Breaking Barriers with PCR: Innovative Solutions for Clinical Trial Success

Register now
kitting d'échantillons cliniques (1)

Services d'habillage clinique personnalisés

Pour les essais complexes et les essais de médecine de précision

Intégrer les stratégies de biomarqueurs aux opérations cliniques afin de garantir l'intégrité des échantillons et la conformité aux réglementations.

Dans les premières phases des essais de médecine de précision, chaque échantillon a une valeur significative. Precision for Medicine est spécialisé dans les solutions de kitting sur mesure qui garantissent non seulement une collecte d'échantillons précise, mais aussi le respect des normes les plus strictes en matière de conformité réglementaire. Notre mélange d'automatisation et d'expertise humaine nous permet de nous adapter rapidement à l'évolution des besoins de votre essai, garantissant ainsi que votre recherche progresse sans heurts.

Les installations récemment rénovées de Precision à Frederick, dans le Maryland, et à Berlin, en Allemagne, assurent une couverture mondiale, offrant un partenaire de kitting fiable avec une approche conçue pour répondre aux besoins spécifiques des projets de kitting d'essais cliniques en phase précoce.

Principaux facteurs de différenciation

  • 01 icône-1

    Stratégies de kitting adaptatif

    Adapté pour répondre aux exigences spécifiques des essais de médecine de précision en phase précoce.
  • 02 icône-1

    Conformité réglementaire

    Veiller à ce que tous les processus soient conformes aux normes et lignes directrices les plus récentes du secteur.
  • 03 icône-1

    Écosystème intégré

    Tirer parti d'une expertise complète pour soutenir chaque phase de votre essai.
  • 04 icône-1

    Capacités renforcées

    Les améliorations apportées à nos sites de Frederick (MD) et de Berlin (Allemagne) améliorent notre capacité à gérer les demandes d'essais complexes.

Découvrez comment nous proposons un kitting plus intelligent

Découvrez comment nos solutions de kitting sur mesure soutiennent des essais cliniques complexes. Jetez un coup d'œil à un aperçu rapide de nos capacités globales et à une étude de cas approfondie sur la façon dont le kitting de précision a permis de réaliser un essai de thérapie cellulaire aux exigences complexes.

 Explorer d'autres ressources

Les services de kitting, de collecte d'échantillons et de logistique de Precision fournissent :

kit tubes

Développement de kits et gestion de l'approvisionnement

  • Essais et visites spécifiques
  • Types d'échantillons multiples
  • Traçabilité de chaque composant et des dates d'expiration via un LIMS conforme à la 21CFR Part 11
  • Rapports détaillés sur l'état des kits
  • Formation au prélèvement d'échantillons
Collecte de sang-1

Formation des sites cliniques

  • Plans d'assurance qualité spécifiques à la collection
  • Développement de la documentation de formation
  • Programmes de compétence et de suivi
logistique globale-1

Logistique et gestion des transports

  • Permis d'exportation/importation
  • Travail en horaires décalés pour recevoir les livraisons et résoudre les problèmes d'expédition.
  • Connaissance de la planification du meilleur chemin pour l'expédition
  • Options d'expédition à température ambiante, réfrigérée ou congelée
  • Expérience avec les principaux transporteurs, par exemple QuickStat, World Courier, FedEx, Marken.

Découvrez les autres services de laboratoire central de Precision

  • Explorer
    PBMC
    traitement des échantillons

    Traitement des échantillons et des PBMC

    Traitement des échantillons avec une expertise dans les isolations de PBMC provenant de laboratoires répartis sur les 5 continents

    Explorer
    traitement des échantillons

    Traitement des échantillons et des PBMC

    Traitement des échantillons avec une expertise dans les isolations de PBMC provenant de laboratoires répartis sur les 5 continents

    Explorer
  • Explorer
    vignette de la carte de biostorage
    échantillons biologiques

    Biostockage

    Stockage des échantillons dans toutes les conditions et à toutes les températures, accès rapide aux échantillons et accès à l'inventaire en ligne

    Explorer
    échantillons biologiques

    Biostockage

    Stockage des échantillons dans toutes les conditions et à toutes les températures, accès rapide aux échantillons et accès à l'inventaire en ligne

    Explorer
  • Explorer
    LabEportal

    Portail électronique du laboratoire de précision

    La visibilité en temps réel de l'état du projet, de l'échantillon, du kit et de l'expédition permet d'accéder 24 heures sur 24 et 7 jours sur 7 aux données essentielles de l'étude.
    Explorer

    Portail électronique du laboratoire de précision

    La visibilité en temps réel de l'état du projet, de l'échantillon, du kit et de l'expédition permet d'accéder 24 heures sur 24 et 7 jours sur 7 aux données essentielles de l'étude.
    Explorer

Explorer le blog de Precision

Lisez notre blog pour en savoir plus et découvrir les travaux soutenus par Precision.

Découvrez notre blog
Read: Has the rest of the world finally caught up with Latin America? Has the rest of the world finally caught up with Latin America?

Clinical Trials

Has the rest of the world finally caught up with Latin America?

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=220405672474, hs_child_table_id=0, hs_updated_at=1788379304461, hs_published_at=1788379322226, description=Andrés Bayona, MD, MBA, is a tenured physician and healthcare executive with over 30 years of experience spanning clinical practice, healthcare management, and global clinical research operations. He holds a specialization in Internal Medicine, as well as advanced degrees in Health Services Management and an MBA. In his role as VP, Clinical Operations, his many years in CRO and global Pharma roles and deep connections within the Latin American healthcare industry make him uniquely qualified to guide our growth strategy in Latin America., avatar=Image{width=240,height=360,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Bayona_Andres_1445.jpg',altText='Bayona_Andres_1445',fileId=220973350833}, lastname=Bayona, hs_initial_published_at=1787769344448, hs_created_by_user_id=65712240, hs_created_at=1787769297292, hs_is_edited=false, hs_deleted_at=0, name=Andrés, job=Vice President, Clinical Operations, slug=andres-bayona, hs_updated_by_user_id=65712240}, second={}, third={}})
  • Andrés Bayona avatar

    Andrés Bayona
Découvrir
Read: Case Study: Rapid Execution of Assay Validation Rescued Global Study Case Study: Rapid Execution of Assay Validation Rescued Global Study

Translational Research - Assays

Case Study: Rapid Execution of Assay Validation Rescued Global Study

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1788379322226, description=Christie Bongel is a scientist by training, but her true passion lies in leadership, particularly in building leaders and shaping high-performing, trust-based cultures. She believes that many talented bench scientists are promoted into management roles without formal leadership development and is committed to helping close that gap. While culture and people development may not always appear on a balance sheet, she views them as essential drivers of long-term organizational success. As a leadership-focused operations executive, Christie leads laboratory operations and strategy within a global network, partnering with pharmaceutical and biotechnology organizations to navigate complex oncology challenges. Her work spans translational oncology, clinical trial strategy, and laboratory execution, with a focus on translating scientific and operational complexity into clear, actionable strategies that drive meaningful outcomes., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1781614819314.png',altText='Christie Bongel',fileId=219203862915}, lastname=Bongel, hs_initial_published_at=1786473638412, hs_created_by_user_id=65712240, hs_created_at=1786473568408, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director, slug=christie-bongel, hs_updated_by_user_id=65712240}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1788379322226, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, position=Vice President, IVD Regulatory Consulting, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=65712240}, third={}})
  • Christie B. avatar

    Christie B.
  • Kennon D. avatar

    Kennon D.
Découvrir
Read: Clinical AI at Scale: Why Trust Matters More Than Speed Clinical AI at Scale: Why Trust Matters More Than Speed

Clinical Trials

Clinical AI at Scale: Why Trust Matters More Than Speed

|
    has third author: false, (SizeLimitingPyMap: {main={hs_id=219402396746, hs_child_table_id=0, hs_updated_at=1787057935787, hs_published_at=1788379322226, description=Zulfat Kapadia is a Statistical Programmer with a scientist's heart and a programmer's precision, bringing over 11 years of experience in clinical data analytics. She currently works as a Statistical Programmer at Precision for Medicine, focusing on clinical data transformations and safety analytics. She is a SAS-certified Statistical Programmer with strong expertise in CDISC standards (SDTM and ADaM), turning raw clinical data into clean, submission-ready datasets and TLFs (Tables, Listings, and Figures). Her journey began with an M.Sc. in Microbiology from Gujarat University, followed by years as a Research Associate, where she worked hands-on with method development, validation, and LC-MS/MS analysis in GLP-regulated labs, including navigating regulatory audits. She later moved into SAS programming at Cognizant, building the technical foundation for her current specialization. A resourceful team player, she continues expanding her expertise across clinical and pharmaceutical domain., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Zulfat%20Headshot.jpg',altText='Zulfat Headshot',fileId=219402357006}, lastname=Kapadia, hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786648684030, hs_is_edited=false, hs_deleted_at=0, name=Zulfat, job=Statistical Programmer, slug=zulfat-kapadia, hs_updated_by_user_id=65712240}, second={hs_id=219402396744, hs_child_table_id=0, hs_updated_at=1786648683717, hs_published_at=1788379322226, description=As Principal Statistical Programmer, Shakila plays a key role in leading statistical programming activities for clinical development programs at Precision for Medicine. She has extensive experience managing study deliverables, supporting regulatory submissions, implementing CDISC standards, and collaborating with cross-functional teams to ensure high-quality and compliant clinical data outputs. Prior to joining Precision for Medicine, she held programming roles at ICON and Quintiles, where she contributed to global clinical trials across Oncology, Cardiovascular, Vaccine, and Diabetes therapeutic areas. She has led the development and validation of SDTM, ADaM, TLFs, define.xml, and submission-ready datasets for major health authorities including the FDA, PMDA, and EMEA. Beyond her expertise in SAS programming and clinical data standards, Shakila is passionate about process improvement, automation, and mentoring teams. She has recently expanded her capabilities in Data Science, gaining practical experience in Python, Machine Learning, R, and Tableau, and is keen on leveraging modern analytics and AI-driven approaches to enhance clinical research solutions., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Shakila%20J%20Headshot.png',altText='Shakila J Headshot',fileId=219402114740}, lastname=Jagadeesan , hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786648634345, hs_is_edited=false, hs_deleted_at=0, name=Shakila, job=Principal Statistical Programmer , slug=Shakila-Jagadeesan, hs_updated_by_user_id=65712240}, third={hs_id=219402097154, hs_child_table_id=0, hs_updated_at=1786648633237, hs_published_at=1788379322226, description=As Senior Manager of Statistical Programming, Sugumaran brings a wealth of experience to his role at Precision for Medicine, since March 2021. Prior to Precision for Medicine, he was associated with ICON Clinical Research for over 10 years across various roles in statistical programming. He has been actively involved in leading large and complex submissions for a diverse client base including large biopharma, biotech, and CROs. In addition to building his expertise in statistical programming, data analytics, and data visualization, he is deeply passionate about developing talent and cutting-edge software solutions. He is also actively involved with several social causes and CSR activities. Sugumaran holds an MBA in Pharmaceutical Management and a Master's in Bioinformatics. He is also currently pursuing a PhD in Bioinformatics., avatar=Image{width=1024,height=1536,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Sugumaran%20headshot.png',altText='Sugumaran headshot',fileId=219402130472}, lastname=Muthuraj, hs_initial_published_at=1786648737451, hs_created_by_user_id=65712240, hs_created_at=1786647962706, hs_is_edited=false, hs_deleted_at=0, name=Sugumaran, job=Senior Manager, Statistical Programming , slug=Sugumaran-Muthuraj, hs_updated_by_user_id=65712240}})
  • Zulfat K. avatar Shakila J. avatar Sugumaran M. avatar

  • Zulfat K.

    Shakila J.

    Sugumaran M.
Découvrir
Loading...