SRL provides the comprehensive support for pharmaceutical research and development through clinical trials specimen analyses and CRO business

• Fundamental research and non-clinical studies
• Other services

Fundamental research and non-clinical studies

Companion diagnostcs

For surrogate markers, novel biomarkers that are indispensable for pharmaceutical development, we will work together with affiliated companies, providing help up to submission to the regulatory authorities.

　

　

Establishment of various biomarker measurement systems

The presence of intracellular and intra-tissue proteins expressed by the target genes can be detected by immunostaining the proteins expressed by genetic coding. This is essential for the development of drugs that targets molecules.
We are well experienced with biomarker screening from the drug discovery stage to Phases I to III. We provide GCP-based clinical trials support.

　Various biomarkers:

• EGFR（HER1）
• HER2/erbB2
• K-RAS
• C-KIT（DNA）
• FGFR
• EML4-ALK
• c-Met

　and other biomarkers

Pharmacokinetics (PK) / Toxicokinetics (TK) studies

Various validation studies are carried out at our GLP-compliant facility. Using cutting-edge instruments, we will support the validation study beginning from the establishment of the analysis system.

Capabilities for GLP validation studies

1.TK analysis

2.Analyzing drug concentrations in materials prepared for administration

Capabilities for GLP-applicable studies

1.Validation of analysis methods

2.Analyzing drug concentrations in body tissues in non-clinical studies

3.Analyzing drug concentrations in body tissues in clinical trials

4.Analyzing various hormones and cytokines

5.Analyzing antibodies against drugs

6.Biologics studies

• Various quality tests
• Viral clearance tests

　

　

Anti-drug antibody (ADA) analysis

ADAs can lead to adverse side effects with biopharmaceuticals of human origin. ADAs analysis is now required for regulatory submission for the development of protein therapeutics.
We analyze ADAs in serum and plasma for various biopharmaceuticals.

　

　

Central Laboratory for Clinical Trials

The Central Laboratory for Clinical Trials is completely separate from the Clinical Testing Laboratory, is run as an entirely independent laboratory specialized in analyses for clinical trials, and is capable of performing various types of analyses in accordance with clinical-study-related regulations (GxP). The samples and study materials, etc. and our computers are located in highly secured rooms.

Data management system in compliance with Japanese and US regulations and policies

NuGenesis Scientific Data Management System (SDMS) by Waters is used as the core of the testing system in our data management system. It is in compliance with 21CFR Part 11 (Part 11), US Food and Drug Administration (FDA) regulation, and "Guidance for use of electromagnetic records and electronic signatures in connection with pharmaceutical regulatory submissions, etc." (ER/ES), a notification from the Director of the Pharmaceutical and Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare.

Common analyses performed by the Central Laboratory for Clinical Trials

• Studies that are compliant with, or that apply, the ministerial ordinances relating to specifications for performance of safety-related nonclinical studies on pharmaceuticals (GLP)
• Studies that are compliant with ministerial ordinances relating to specifications for performance of clinical trials on pharmaceuticals (GCP)
• Various types of viral safety tests (viral clearance tests, viral confirmation tests, spike tests, etc.)
• Tests for international clinical trials: Support for clinical trial tests by specialist coordinators, clinical trial tests commissioned by overseas clinical research organizations (CROs), and clinical trial tests in compliance with Part 11 and/or reporting systems, etc.
• General Test Room (for biochemistry, hematology, urinalysis, and other safety evaluation tests), Esoteric Test Room (for EIA RIA, etc.), Chromatographic Analysis Room (for HPLC, LC/MS/MS, etc.), PCR Test Room, and P2 Test Room

Certification and Accreditation: Central Laboratory for Clinical Trials

• CAP
• GLP
• ISO15189
• CLIA

Central laboratory service

Project management

Capabilities

• Phase I, II, and III clinical trials
• Bioequivalence studies
• Post-marketing studies

　

　

Analyses of specimenss

SRL, as a leading company in the field of clinical laboratory testing, is able to meet a wide range of analyses needs, using advanced testing technologies. We can perform biochemistry tests, endocrinological tests, tumor-related tests, virological tests, immune serum tests, cellular immunity tests, gene-related tests, chromosomal tests, pathology tests, etc. as the bases. The various other analyses we perform also include immunohistochemistry (IHC) tests, flow cytometry (cell surface markers and intracellular cytokines), pharmacogenomics (PGx), peripheral blood mononuclear cell (PBMC) tests, multiplex assays (electrochemiluminescence), and mutation analysis by real-time PCR.

In terms of the latest technologies, we can meet your requirements by performing mutation analysis using next-generation sequencers, analyses of various parameters, establishing analyses systems by validation, and tracing measurement systems.
For example,

With introduction of the most advanced analytical equipment, we can measure drug concentrations in biological samples. We have the capabilities to analyze all compounds ranging from low to high molecular weight. For vaccine development, colored images are scanned and counted using the latest analyzers, and the statistical significance is evaluated.

Kits Preparation

The use of correct sampling kits and the procedures play an important role in the specimen collection in accordance with the study protocol. We prepare sample collection kits in accordance with study protocol requirements. Our sample collection kits include requisition forms, blood collection tubes, transport tubes, on-site sample processing procedures. Sample collection kits are built integrating requirements of nationwide clinical sites, and information of sites accumulated by our long-term experiences and achievement.

　

　

　

Request Kits Online

Sizai-Navi is a specialized web portal. You can requests kits, and view kits building status online.

Main features

• Request kits
• Specify delivery date and time
• Kits preparation status
• Kits shipment history
• Kits expiration dates

Specimen Pick-up

SRL have extensive information of clinical sites. This allows us to provide specimen pick-up services to meet sites' requirements all over Japan that participate in clinical studies. Specialized specimen pick-ups can also be arranged in order to meet various operations and requirements consistent with study protocols. In addition, specimens can be picked up for temporary storage, not for analyses at SRL, until shipped to another reference laboratory in Japan or overseas.

Request Specimen Pick-Up Online

Site-Navi is a web portal designated to schedule specimen pick-up and review scheduled pick-up. Specimen pick-up can be scheduled online from PC and smartphones, etc.

Main features

• Schedule a specimen pick-up
• Check the status of pick-up request
• Cancel or modify the scheduled pick-up
• Pick-up history

　

　

Specimen storage

Valuable samples that cannot be obtained again are stored until study completion.

Specimens are stored in accordance with the sponsor’s requirements. These requirements are set an d agreed by the sponsor prior to the beginning of the study. The storage requirements are described in “Test materials / Stipulated duration / Stipulated conditions,” All specimen types: serum, plasma, pathology blocks, and pathology slides, are stored at their optimal temperature, such as room temperature, -20ºC, or -80ºC. Specimens that are not analyzed by SRL, such as PK and PD specimens, can be also stored.

Samples received at our facility are stored under conditions of strict temperature control, in a freezer set at -20ºC or an ultra-low-temperature freezer set at -80ºC. We can arrange the shipment to a reference laboratory.

We can also ship in liquid nitrogen for materials that require ultra-low-temperature shipment, including PBMCs, and materials for regenerative medicine. Please feel free to discuss further with us. In addition, we can temporally store PK specimens that are collected in internationally collaborative studies, etc. and arrange shipments to a reference laboratory in Japan or overseas.

　

　

　

　

　

ALCOA

New ALCOA compliant reporting services

In recent years, the number of internationally clinical trials has increased. This has led the source documents to be prepared ALCOA compliant, the international data integrity standard. To address this, we now provide new reporting services, enabling the physicians to record (signatures and dates) that they have reviewed the abnormal test results.

What is ALCOA?

The five fundamental requirements for source documents, whether paper or electronic, defined by FDA are shown below. These requirements stand for the acronym "ALCOA".

• Attributable: It can clearly be shown to whom documents attribute to, or who is responsible for them.
• Legible: Documents are readable and easily understood.
• Contemporaneous: Activities are recorded at the time they occur
• Original: Documents are the original versions. That is, they are not photocopies* or transcriptions.
• Accuracy: Documents are error-free.

*This requirement excludes certified copies, that is, photocopies that are assured to be identical to the originals.

　

　

PGx banking

PGx banking services

We provide comprehensive service, from specimen pick-up, to DNA extraction, secondary coding, and long-term storage. We can also arrange specimen shipment, and carry out PGx-related analyses and genetic analyses to meet your request.

Storage in our fully-equipped facilities

• Specimens are stored in ultra-low-temperature freezers set at -80ºC, assuming long-term storage,
• Storage area is restricted, only accessible by authorized personnel.

　

　

Complete back-up system

• The ultra-low-temperature freezer is connected to an emergency power source, allowing the power supply even in the event of power outage.
• The ultra-low-temperature freezer is equipped with a temperature-recorder and warning system, and responds immediately in the event of temperature increases or other deviations.

　

　

Management System

• Specimens are managed by barcodes. Secondary coding by persons responsible for management is also possible.
• Various types of log management are in place. (entry/departure records, and room entry log for authorized personnel)
• These records are controlled in accordance with “Act on the Protection of Personal Information,” and “SRL’s Genetic Ethics Guidelines.”

　

　

Specimen shipment and analysis services

• Specimens are shipped to the specified addressee as requested.
• Specimens can also be received from, or sent, overseas.
• Essential data analysis is carried out using SRL’s genetic analysis technology.

　

　

Clinical trial data center system (CRAD)

Using the clinical trial data center system (CRAD), you can review and download clinical laboratory test results online. We have established this system by utilizing knowledge and know-how obtained in the course of tasks relating to clinical trial specimens so that physicians, study coordinators, and CRAs involved in clinical trial management are able to progress clinical trials smoothly and safely.

　

　

Principal functions of CRAD system

• Review and download the specimen receipt status (HTML/Excel)
• Review and download test results (PDF/Excel)
• Review and download case progress information (PDF/Excel)
• Review and download the test results alarm (Excel)
• Download test results (txt file in CSV format)
• Alert email notification
• English/Japanese display feature

　

　

High efficiency

Appropriate layout

Our proprietary design, specifically for clinical trials.

Laboratory results released up to the past 5 days are shown in the top screen. This will allow the users to review the laboratory results that are required to determine the subject’s enrollment eligibility. The history of each subject can be viewed in the test result information list. Also, the subject’s study progress and alerts can be reviewed from the list.

Reassurance (assistance)

Alarm feature

Pre-set laboratory abnormalities are highlighted. This helps prevent missing the laboratory abnormalities.

I If the test results indicate abnormalities, abnormal fluctuation, and combination of specific conditions specified by the client, alert is generated. Alert notification can also be sent via email, informing you of the alert without logging into CRAD. In the clinical trials that require monitoring for drug-induced liver injury (Hy’s law), certain criteria can be highlighted and users are notified via email to ensure that the study is carried out safely.

Timeliness

Timely updates

You can monitor the specimen information received at our laboratory and the test results in CRAD.

The most up-to-date specimen receipt status, test results information, and clinical trial progress information are updated on CRAD once a day. Utilizing SRL’s nationwide specimen pick-up and courier network, the specimens from sites arrive at our facility in the following morning. The specimens are accessioned and sent to analyses. The results are reported on the next business day. *1
*1: The turn around time of the test results differs depending on the test item.

Safety (security)

Absolutely reliable security system

Important clinical trial information is protected by highly rigorous measures.

In order to access CRAD, a user needs to import a client certificate on each computer. User ID, and passwords linked to the ID are required. This helps stronger security is in place, and to prevent unauthorized log-in using your credentials. CRAD-related servers are located at data centers with highest security standard in Japan. SSL encryption, multiple firewalls, and up-to-date anti-virus software are utilized to maintain a high security level 24/7.

Convenience (appropriate)

Users can easily navigate with the features intended for specific purposes.

Data available on CRAD can be downloaded. The data can be downloaded in HTML、EXCEL, PDF and/or CSV.

Easy to use (support)

Help Desk

Help Desk provides any additional assistance.

If you have any questions regarding CRAD, please contact our Help Desk. Frequently asked questions are listed in Q&A.

Users' review

Physician
I can obtain the printout from the study coordinator in a timely manner. I do not personally log into CRAD, but the hard-copy information is easy to understand and helpful.

Study Coordinator
I use CRAD several times a day because I can review the study progress and schedule for each subject. I can check the subject’s upcoming test schedules in CRAD. This feature enables the accurate progression, which is helpful. In addition, when we share the information with physicians, test results can be downloaded in Excel. We can add essential information and pull the information. The system is easy to use.

CRA
The up-to-date test data can be reviewed on the top screen. This is convenient when we need to know the results quickly. In addition, with alert values set for multiple conditions, you become immediately aware of abnormal test results and can perform safe medical treatment, which is very helpful.

CRA's project manager
I always check CRAD to view the test results and subject progress status. CRAD allows sharing the comprehensive information with CRAs who often go on business trips or work out of the office.

Personnel responsible for international clinical trials
CRAD can be provided in English, so the test results from sites in Japan can be reviewed in English. Even international clinical trials can be managed without stress.

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