PPD clinical research business of Thermo Fisher Scientific

PPD's dedicated clinical research business offers early phase oncology and hematology clinical trial services, including first-in-human and Phase I/II trials, focusing on safety, dose, side effects, and initial efficacy of cancer therapies.

PPD Laboratories GMP lab provides comprehensive biologics analysis services including characterization, method development, stability testing, quality control, and release testing for APIs and finished products. It supports a wide range of biologic drugs and advanced therapies with high-quality analytical services.

Comprehensive analytical services supporting mRNA replacement therapeutics programs, including assay design, method development, validation, and regulatory consulting.

Global clinical trial and post-marketing reporting capabilities backed by robust regulatory intelligence for individual case and aggregate report submissions to regulatory authorities, ethics committees/institutional review boards and investigators.

A streamlined, systematic approach to safety submissions for regulatory authorities, ethics committees, and investigator sites, supported by a global team of 120+ professionals.

Molecular RT-PCR assay targeting SARS-CoV-2 Nucleocapsid protein (N), Spike protein (S), ORF1ab and MS2 phage for qualitative analysis.

Serology ELISA cut-point assay targeting SARS-CoV-2 full length spike protein recombinant protein (aa16-1214, S1+ S2).

Serology electrochemiluminescent (ECL) assay using recombinant nucleocapsid (N) antigen for antibody determination against SARS-CoV-2.

Biomarker dual-target assay measuring levels of IL-6 in serum.

A comprehensive AI-driven platform providing immediate visibility into clinical trials, enhancing efficiency, reducing complexities, and ensuring faster trial completion with high-quality results. It integrates clinical milestone monitoring, risk prediction, material management, and tracking.

360° CDMO and CRO solutions combining clinical research organization and contract development and manufacturing organization expertise and technology to streamline drug development from concept to market.

Strategic clinical development consulting solutions combining clinical development and regulatory strategy with pre-clinical and IND-enabling consulting and Phase I-IV trial design, leveraging expertise from Thermo Fisher Scientific.

Complete, end-to-end outsourcing of clinical trial tasks from study startup through database lock, supporting trials at any phase from early development through Phase II and III and into peri- and post-approval.

Comprehensive drug substance / drug product (DS/DP) analytical testing with first-time accuracy, focusing on chemistry, manufacturing and controls (CMC) lab services for small molecules and biologics across all phases of drug development.

Expert biomarker services including flow cytometry, ligand binding, LC-MS, and genomics with customized strategies including biorepository, sample/data management, logistics, and kitting.

A data management solution revolutionizing the drug development process, offering global solutions with flexible models including full-service, select services, hybrid brick-and-mortar/mega-site services or functional service provider (FSP) partnerships spanning all time zones for 24-hour coverage.

Working with a cell and gene therapy CRO across the development lifecycle to foster better integration of services and capabilities throughout ATMP clinical trials.

PPD Laboratory services’ bioanalytical lab offers chromatography and LC-MS/MS analysis for a wide range of compounds from small molecules to antibody-drug conjugates with advanced automated sample cleanup and stable isotope internal standards for precise quantitation.

Provides comprehensive and full-service bioanalytical and biomarker solutions with advanced technologies and methodologies to support small and large molecules, including complex modalities like ADCs, mAbs, and ATMPs.

Comprehensive regulatory services offered by PPD, a clinical research business of Thermo Fisher Scientific, providing scientific, regulatory, and operational expertise to navigate regulatory approval and market access for pharmaceutical and medical device products.

Focuses on advancing innovation in chromatography, molecular genomics, sample preparation, and proteomic technologies and methodologies, supporting multiple modalities including small molecules, peptides, antibodies, oligonucleotides, and cell & gene therapies.

Platform supporting site activation and startup by mapping out startup and activation processes in 60+ countries and establishing workflows per country-specific regulations and investigator requirements.

Multi-functional lab providing global expertise with local operations, offering high-quality data for bioanalytical, vaccine sciences and central lab services to advance clinical trials.

Advanced viral safety testing services including in vitro adventitious viruses assays, ViralSEQ real-time PCR assay for minute virus of mice, replication-competent assays for adeno-associated virus and lentiviruses, and Product-Enhanced Reverse Transcriptase (PERT) assay.

PPD Laboratories offers bioanalytical laboratory services leveraging liquid chromatography tandem-mass spectrometry (LC-MS/MS) techniques for the development and validation of biologics, supporting pharmaceutical development at any stage.

A flexible, scalable, and system-agnostic technical solution designed to support clinical trial monitoring by managing SDV and SDR activities efficiently while ensuring data integrity and regulatory adherence.

Provides integrated lab support for clinical trials, biomarker assessments, and safety testing as part of a global clinical trial lab network.

PPD Laboratory Services offers molecular genomics testing in a custom-built suite with engineering controls to minimize contamination, featuring advanced genetic analyzers and sequencing systems.

Proven expertise to help execute a successful biosimilar program.

Multifunctional system providing end-to-end workload management and metrics reporting with ability to auto-file into electronic document management system or electronic trial master file (eTMF).

Complete life-cycle management including packaging, labeling, and distribution of medical and pharmaceutical supplies through Thermo Fisher Scientific's global cGMP facilities.

Artificial intelligence and machine learning tools to guide study design, country/site selection, forecast and manage study timelines, model study trajectory, and identify and mitigate risks.

Profiling of tumor and plasma samples using Oncomine assays with CE-IVD option, multiplexed gene panels, and detection of mutations, copy number variants, and fusions with high sensitivity.

An extensive suite of case processing options with or without medical review, for both clinical trial and post-marketing cases, processing over 500,000 initial and follow-up versions each year with a >99.9% on-time completion compliance rate.

Comprehensive Phase I clinical trial services including first-in-human studies, complex study design, and customized solutions to fit unique compound and study objectives.

Automates the generation, delivery and tracking of ICSR submissions to regulatory authorities and ethics committees.

Over 30 years of experience in vaccine development offering full-service capabilities.

Regulatory guidance and support in CMC development including regulatory submissions, GMP audits, and contract manufacturer identification.

GVP-compliant signal management services including detection, validation, assessment and tracking, supported by M-SERM physicians and safety scientists analyzing safety data and concluding on product safety profiles.

Consulting services to establish or modify pharmacovigilance systems and meet regulations in unfamiliar geographical regions, providing customized safety solutions.

Extensive knowledge of oncology and hematology CRO services with research, vast capabilities, and experience with feasibility studies and a large investigator network.

Patient-centric solutions advancing rare disease CRO research globally.

Biomarker assays including large and small molecules using multiple LC-MS technologies with high throughput sample preparation and advanced chromatography techniques.

Global network of 47 early development sites across 11 countries offering access to diverse healthy volunteers and specialty populations for Phase I clinical trials.

Comprehensive services for clinical document submission and publishing, including scanning, document publishing, data conversion, and global submission publishing.

Multifaceted therapeutic expertise for CNS clinical trials differentiating PPD's neuroscience clinical research team.

A one-stop regulatory intelligence platform used by PPD staff to source global regulatory intelligence, support clinical trial, marketing authorization, lifecycle management, safety reporting, and CTMS document requirements.

A named project-management professional empowered to make independent decisions to ensure global biomarker study success, ensuring timely shipping and streamlining communication.

High-quality analytical testing laboratory focused on meeting customers' needs in Europe, Middle East, and Africa (EMEA).

End-to-end literature safety surveillance activities supporting clinical trial and post-marketing activities, including ICSR detection and review for signal detection purposes.

Early development service performing absorption, distribution, metabolism and excretion (ADME) studies to understand drug processing in the human body for safety and efficacy assessment.

Experience across a broad range of cardiovascular indications with an investigator network of more than 6,000 cardiologists.

Serology functional cut-point plate-based neutralizing antibody (NAb) assay detecting anti-spike antibodies that disrupt ACE2 to SARS-CoV-2 spike binding.

Over 15 years of QPPV experience including setup and maintenance of complex global pharmacovigilance systems, participation in non-routine pharmacovigilance activities, and extensive experience in PSMF and SDEA authoring/management.

Experience in critical care to overcome common challenges and quickly move programs forward.

Full capabilities to fulfill adjudication/clinical endpoint committee (CEC) and data safety monitoring board (DSMB) requirements with dedicated staff experienced in commercial and government sponsored global studies.

A tool that optimizes operations by supporting timely and compliant management of end-to-end regulatory processes, including planning and tracking documents, submissions, registrations, commitments and more.

Full range of aggregate safety report and risk management plan writing capabilities for clinical trial and post-marketing needs, including DSUR, PBRER, PADER, EU-RMP.

Biomarker flow cytometry assay measuring markers CD45, CD3, CD4, CD25, FoxP3, CD8, PD-1, NKGD2A for quantitative monitoring.

Assay to detect replication-competent adeno-associated virus in biologics and cell and gene therapies.

Team of 40+ physicians providing safety and medical expertise across the product lifecycle, supporting clinical trials and post-marketing safety, including ICSR review, literature review, aggregate safety reports, signal detection, risk management plans, and clinical trial safety consultation.

Biomarker multiple platform assays for IL1-ra, MCP-3, IL-18, HGF, MIG, M-CSF, G-CSF, MIG-1a, CTACK.

Expert team of physicians and pediatric specialists creating meaningful strategies for pediatric therapeutic research.

Infectious disease contract research organization services delivering data to support clinical development strategies.

Specialized knowledge and services to optimize vaccine programs, providing regulatory insights, real-world evidence proficiency, patient-centered enrollment solutions, economic modeling, and health technology assessment submissions.

Flow cytometry assays including immune profiling, receptor occupancy, CAR-T cell enumeration, intracellular phospho-flow, and intracellular cytokine secreting cells by flow cytometry and ELISpot, with compliance to CAP/CLIA, GLP and GCLP.

A publishing solution that expedites the delivery and validation of regulatory submissions by creating regulatory-compliant PDF files and validation tools to ensure quality published outputs satisfy technical requirements for health authority gateways and portals.

Cloud solution to streamline and automate site selection and activation of top-performing clinical trial sites, delivering 30% reduction in study startup cycle times.

A GMP-compliant PCR assay for rapid and expanded species coverage mycoplasma testing in biologics and cell and gene therapies.

Qualified Person (QP) Release services ensure investigational medicinal products (IMPs) are released smoothly in Europe by providing effective communication and transition management with external contractors, facilitating regulatory compliance and timely shipment to clinical trial sites.

Service for material profiling in extractables and leachables studies to support container/closure selection and manufacturing process qualification.

Comprehensive hepatology contract research organization services.

Endocrine and metabolic disorder expertise including diabetes, providing combined clinical efforts.

Molecular anatomic pathology and specialty testing for drug discovery, companion diagnostics (CDx) and in vitro diagnostics (IVD) validation studies to support oncology, including immunohistochemistry, chromogenic in situ hybridization, and molecular studies.

Award-winning lab with expertise in complex and multiplex cell-based, functional, serological and molecular assays supporting program development from pre-clinical through post-approval.

Biomarker flow cytometry assay measuring percentage of B-cells, T-cells, and natural killer cells in blood.

Global rheumatology and immunology CRO experience with expert teams for clinical trials and research.

Biomarker flow cytometry assay measuring markers CD45, CD3, CD4, CD8, CD56, Ki-67, HLA-DR, CD38 for quantitative monitoring.

Expertise in gastroenterology protocols provided by a global clinical development team.

Biomarker/Functional ELISPOT test measuring frequency of immunoglobulin-secreting B cells and identification of specific cytokine-secreting T cells.

In-depth clinical trial expertise in nephrology and renal disease.

Expertise in ophthalmic research with therapeutic-specific ophthalmic vendors and an international network of experienced investigative sites.

Comprehensive regulatory consulting and intelligence services provided by senior pharmaceutical regulatory experts to develop global registration strategies and ensure compliance with regional and local regulatory requirements.

Biomarker flow cytometry assay targeting pro-inflammatory cytokines with CAP/CLIA potential for quantitative measurement.

Biomarker cytokine/ligand binding kits available for independent cytokines or as a 4-plex panel.

Clinical development expertise in dermatology protocols with a global team of more than 800 professionals.

Serology functional pseudoneutralization assay detecting virus-specific neutralizing antibodies to SARS-CoV-2.

Biomarker flow cytometry surface marker panel (CD45,CD3,CD4,CD8, CD19,CD16/CD56) for immune cell quantification.

Experience in conducting Phase I-IV and consumer health women’s health studies including thousands of patients and hundreds of sites.

Experience in respiratory clinical trials including a range of indications.

Assay for detection of retroviral reverse transcriptase activity as part of viral safety testing.

Biomarker cytokine/ligand binding kits available for independent cytokines or as a 6-plex panel.

Testing services including specific IgE blood testing, plasma protein determination using BN II System and Cobas, and validated ELISA assays for multiple interleukins to support immune response and inflammation studies.

Extensive experience in planning and implementing Phase I-IV programs for urology studies in all major markets.

Cytotoxicity assay testing LDH levels in blood and bodily fluids released by tissues.

ECL assay testing amount of ferritin circulating in blood for quantitative monitoring.

Biomarker cytokine/ligand binding panels including Cytokine Panel 1, Proinflammatory Panel 1, Chemokine Panel 1, Vascular Injury Panel 2, Angiogenesis Panel 1.

Immunochemiluminescent assay testing CRP level in blood.

ELISA test measuring protein fragment levels in blood indicating blood clot formation and breakdown.

ECL assay testing procalcitonin levels in response to tissue injury or bacterial infection.

ELISA test measuring cardiac-specific troponin levels in blood.

Molecular RT-PCR Automated assay with dual-target RdRp and N-genes for qualitative diagnostic use.

Biomarker ELISA tests measuring proteins essential for blood clot formation.

Molecular alternative upper respiratory infection nucleic acid amplification test (NAAT) targeting related molecules.