Services: Central Laboratory Service

Comprehensive Services

Central Laboratory Service

(Affiliated with PRODIA Clinical Laboratory)

Prodia the CRO has affiliated with Prodia Clinical Laboratory, as Central Laboratory in providing a wide range of laboratory testing services. Being one of the largest and the best clinical laboratories in Asia for 36 years, Prodia clinical laboratory serves many clinical trials through its 224 outlets in Indonesia and provides many services in laboratory testing.

Our Central Laboratory conducts many clinical trials compliance with their quality policy : QUALITY AS A WAY OF LIFE, as quality has become the first priority in their activities from the time subjects are prepared for specimens collection up to final data analysis without having to disregards the turn around time.

Proof of commitment in quality as a Central Laboratory in Indonesia for global service (clinical trial world wide) :

1. The first clinical laboratory in Indonesia with ISO 9001 & ISO 15189 standards
2. Member of National Committee for Clinical Laboratory System - NCCLS (USA)
3. Extensive internal quality control procedures (performed by Technical Quality Assurance Unit)
4. Extensive external quality control procedures (RCPA Quality Assurance Programs - Australasia, EQAS- Biorad, PNPME - Dept. of Health Republic of Indonesia)
5. Comprehensive quality assurance programs and compliance to GLP procedures
6. Best 100 performance in worldwide third party quality assessment

Central Laboratory Services and Facilities

1. The broadest menu of Laboratory tests

Having the ability to analyze more than 500-kind of tests, from routine standard safety testing to esoteric testing, Prodia offers any kind of test needed in clinical studies with sophisticated methods (ElectroImmuno Chemiluminescent Assay/ ECLIA, Chemiluminescent Microparticle Immuno Assay/ CMIA, Microparticle Enzyme Immuno Assay/ MEIA, Flourescence Polarization Immuno Assay/ FPIA, HPLC, RT-PCR and more)

Laboratory Test

Routine Test:

- Hematology
- Coagulation
- Clinical Chemistry
- Urine and Feces
- Molecular
- Osteoporosis

Specialized Test :

- Tumor Marker
- Endocrinology
- Microbiology
- CSF analysis

Others Test:

Prodia has also collaborates with Specialty Laboratory (Santa Monica, USA) and NUH Reference Lab (Singapore). Besides having all the access to the latest assays and technology currently available, the number of tests that Prodia able to analyze are increasing through our R&D activities.

2. Rapid Turn Around Time

Prodia achieves extremely rapid turn around time by implementing the latest generation instruments with high throughput. Prodia has supported by integrated system through Laboratory Information System (LIS) and laboratory Automation System (LAS). All specimens performed in Prodia, will be directly analyzes after arrival in our laboratory and (exceptions prevail) results will be reported within 24 hours by means or fax, airmail and email.

3. Specimen storage

Prodia's repository services provide both long-term and short-term specimen storage under optimal conditions for specimen integrity. Prodia maintains specimen at -20oC and -70oC for bank serum, genomic DNA, PK samples, etc. The controlled storage environment has on-site backup system to overcome disruption of electrical service.

4. Flexible Logistic

Preparation, packaging, and delivery of all supplies and materials necessary for specimens collection are managed within the laboratory. Having close cooperation with major courier service allows us to supply trial sites with sampling materials comply with current International Air Transport Regulations (IATA compliant) and thereby guarantee proper transport conditions. Materials can either be provided as visit-specific kits or as generic supplies, yet remaining convenient and easy to use.

Clinical Study Monitoring

Clinical trial is a secondary objectives of business in pharma companies which expense to much money, spending much time and also hiring staffs that may not use all the time, but outsourcing to our CRA can be part of that solution.

Clinical Research Associate (CRAs) of Prodia the CRO are GCP certified. Dedicated CRAs will provide "good, high quality and confidential data of your clinical studies" and produce good studies under a variety of circumstances with investigators and protocols of varying quality, as we understand that poor study monitoring is probably the largest single contributor to inferior study quality

We have our own monitoring strategy to make your trial conduct compliance to GCP, SOPs, protocol through good service in :

a. Study Documents:

Protocols and amendments, EC and regulatory approvals, curriculum vitae, current lab certificates and normal values, drug storage and accountability to include shipping, receipt, dispensing and return records, monitoring records, sponsor and investigator correspondence, investigator brochure, serious adverse events and safety updates.

b. Patient Records:

Patient CRF’s, hospital and/or clinic charts, source documents, supporting CRFs, laboratory reports, X-ray, EKG reports, study visit compliance and dosing compliance.