Clinical Study Services

Make use of NGS to move your clinical study forward

The role of NGS in clinical studies is clearly emerging over the last years, given its manifold applications and the advantages of a rapid, comprehensive, and accurate analysis. NGS helps to uncover disease mechanisms, understand response and resistance to therapies, design new treatment strategies, stratify patients, and identify biomarkers, to name a few. As such, NGS contributes significantly to driving the concept of precision medicine.

Benefit from our long-standing experience in medical diagnostics, genetic analyses and our outstanding NGS offerings. We support you during all steps of your study to ensure the best possible outcome within minimal time.

Getting the Best Results for Your Clinical Study

CeGaT is your partner for NGS services within clinical studies. We understand the requirements and challenges that come with the analysis of clinical samples and offer the respective solutions. That includes the suitable regulatory surrounding, accredited workflows, highest quality standards, and a broad product portfolio to identify the optimal strategy suitable for your project. Our consistent striving of automation, and our high capacity due to state-of-the-art equipment, allows us to offer the fast turn-around times to satisfy your needs. Nevertheless, we can provide the flexibility to customize our analytical processes and adapt the output of our analyses wherever required.

To be in control of the fulfillment of our high requirements, we carry out every step of the process in-house – from sample receipt to the preparation of the final report. We create results you can trust.

Experience & Reliability

  • >12 years of experience in genetic diagnostics
  • all services are performed in-house, including data processing and storage
  • GDPR compliant
  • broad service portfolio
  • superior support with a single point of contact

Consistent, High Quality

  • certified provider: DIN EN ISO 15189, DIN EN ISO/IEC 17025, CAP, CLIA
  • processing according to GCLP standards is possible
  • a high degree of automation
  • LIMS-supported sample tracking and processes

Capacity

  • one of the largest NGS service providers in Europe
  • short turn-around times
  • cost- and time-effective project handling

Our Service to Support Your Study

At CeGaT, we put great emphasis on supporting our customers throughout the whole project. From the planning phase until project completion.

A dedicated expert will be your single point of contact. Through calls on a regular basis, we keep the planning phase efficient. This includes the choice of the right product, the customization of services up to the discussion, and the preparation of the results in the format which fits your needs. Together, we define all quality management, regulatory, and lab-associated aspects.

We offer support tailored to your needs:

  • selection of the optimal sequencing strategy
  • support in project planning and experimental design
  • support in compiling study-relevant documents, like lab manuals, or sample request forms
  • internal training of CeGaT staff, specifically for your study
  • communication with study sites, if requested
  • long-term data storage
  • sample storage
  • provision of standardized sampling kits
  • sample logistics
  • calls with our data analysis experts

Benefit from Our Customized Solutions

We supply you with all the materials you need to conduct your study. Based on our many years of experience, we provide you with optimal support in compiling the documents you need for your study.

We can assist you by providing the following:

  • non disclosure agreement (NDA, CDA)
  • master service agreement (MSA)
  • validation & analytical plan
  • validation & analytical reports
  • work orders

With our sample collection kits tailored to your study, you can safely collect and ship your samples. They are available for different sample materials such as blood, stool, tissue, or saliva. Study-specific labeling of kit components is also part of our service upon request. In addition, we ensure that your kits are delivered to your study centers on time.

Do you need assistance with sample shipping? Our experienced logistics team will be happy to support you and take care of the organization for you.

How We Secure the Data Storage

All data generated during the project remain your exclusive property and won’t be processed outside CeGaT. Secure backup storage of your study data is possible using our iCAS audit-proof archive. We assure that your data is safe with us:

GDPR Compliant

Icon process flow

Germany-Based Servers

Icon process flow

SSL Encryption

Icon process flow

Accredited Workflow

Discover Our Comprehensive Service Portfolio

From single services to comprehensive genomic profiling and longitudinal monitoring of the patient’s therapy response and disease – CeGaTs’ broad service portfolio suits all the questions you raise in your study. Our Services help you to gain multiple insights and analyze several biomarkers parallel from one sample. That will save time, costs, and precious sample material. We are happy to assist you in selecting the optimal services and combining them individually for your project.

We can process various types of sample material, for example, EDTA or PAXgene® blood, fresh frozen/FFPE tissue from resected tumors or biopsies, stool samples, saliva, or liquid biopsies. Low-input options are also available. Dual extraction of DNA and RNA is often beneficial and part of our accredited workflows.

Sample Case – Immune-Oncology Study

Sequencing services provide information on various factors that can be related to a certain illness or monitored throughout treatment. An example of an immune-oncology study, more precisely, a vaccination study, is illustrated below.

Within the initial phase of the clinical study, we characterize the patients using the selected products from our portfolio. In the depicted graph, we use Exome and Transcriptome Sequencing to analyze a blood and a tumor tissue sample. Based on these analyses, we determine the mutation load of the tumor (TMB, MSI), the immune status (HLA), the gene expression profile, and much more. Regular follow-up analyses are conducted after the patients receive the candidate vaccine.

In the monitoring phase, the focus is on the response to the treatment and the early detection of possible relapse. The commonly used analyses include our Liquid Biopsy and Transcriptome Sequencing products, check of the immune status, or microbiome analysis.

CeGaT Is the Best Partner for Sequencing Your Project

High
Flexibility

Scalable for different sample types, quantities, and requirements

Accredited
Procedures

Processing according
to highest quality
standards

Outstanding
Customer Service

Constant scientific supervision of all
project steps

Quality
Made in Germany

In-house processing to maintain our reliable and trusted quality

Contact Us

Do you have a question or are you interested in our service? Feel free to contact us. We will take care of your request as soon as possible.

Start Your Project with Us

We are happy to discuss sequencing options and to find a solution specifically tailored to your clinical study or research project.

When getting in contact, please specify sample information including starting material, number of samples, preferred library preparation option, preferred sequencing depth and required bioinformatic analysis level, if possible.