Designing Case Report Form and Subject Inform Consent
The key to achieving successful clinical studies is the provision of well prepared and detailed study protocols. Whilst the essential core of a protocol should concern itself with study design and methodology in the context of pharmaceutical research and development. This document assumes an extremely important role in recording procedures associated with the entire study conduct with reference to ethical, regulatory and legal requirements.
Prodia the CRO offers you protocol development (including Case Report Forms (CRFs) and subjects Informed Consent).
CRF & Subject Informed Consent
Prodia the CRO provide CRF's design and informed consent's design/translations.
Ethic and Regulatory
Submission and Accelerating Approval letter
Ethics Committee/IRB and Regulatory Authority Submission
Clinical trial should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and in compliance with protocol that has received Ethic Committee approval. Prodia the CRO prepare any related documents and accelerate submission letter of approval from EC and regulatory (BPOM).
Study Management
Selection of Clinical Study Sites and Investigators
Selecting qualified one based on your needs
The conduct of trial is a cooperative venture between the sponsor/CRO, the clinical Investigator, and the Regulatory bodies. The clinical investigator is required to conduct the study in accordance with study protocol, guidance of the sponsor and institutional restrictions.
Prodia the CRO concern about the feasibility process: site (facilities) and investigators (study staffs). Outsourcing to Prodia the CRO, means a key benefit to access information about Indonesian suitable sites or/and investigators in clinical trials. As we have site and investigator's data base and good networking through Indonesia. As such times for the process of budget negotiate and approval may be saved.
Good Clinical Practice (GCP) training for Investigator
Good Clinical Practice is a standard for the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials. The purpose of GCP is to protect human subjects in trials, as well as the general population who will use the products being tested once the products it self are available in the market.
As it important to conducting a trial with knowledge about GCP, Prodia the CRO provide an access to provide GCP course for investigators.
Service of Control and Testing Medicines
Service in Labeling, Randomization, and Conditioning
Prodia the CRO service in Labeling, randomization and conditioning will include but are not limited to: - ensuring that investigational products (controls and testing medicine) are coded and labeled in a manner that protects the blinding. - ensuring that investigational products (controls and testing medicine) are stored in required storage temperatures, condition and times in order to be stable over the period of use.
Delivery of Control and Testing Medicines to Clinical Study Site
For the importance of the condition of investigational products, Prodia the CRO commits to provide services with a safety and timely deliverance for your investigational products.
Subject Screening and Enrollment
Recruitment, retention and subjects compliance are the most difficult aspects of doing clinical trial. Finding, screening and enrolling study subjects are the costliest and time consuming part of Clinical Trial. The timely enrollment of appropriate subjects into trial is critical to manage and it could save time and reduce cost. At the end, it allowing pharmaceutical/biotech for more marketing time before their patent expired. Prodia the CRO offers services in subjects screening, review of inclusion/exclusion criteria, subject enrollment, retention and compliance to sponsor's requirements, needs, budgets, and timeliness.
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 producegood 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. Checking protocol adherence
Checking protocol adherence is make sure that the trial’s conduct compliance with the protocol beside EC, regulatory, SOPs and GCP. Our CRAs will check the following items but are not limited to:
• Subject randomization
• Subject eligibility
•Protocol activities
•Visit schedule
• Drug dispensing
• Others
B.Case Report Form review
We concern about completeness and accuracy of your CRF as we review each page of it in details.
C. Source documents review
Verification of CRF Data with Source Documents including the patient chart, laboratory repots, and other supporting documents for completeness and consistency
D.Inform consent review
Our CRAs concerns about compliance, consistency, and quality inform consents either in pre study, during or post study,we also concerns about any trial/protocol amendments that related to inform consents.
E.Serious adverse event review
Monitoring safety during clinical trial is one of the most important tasks for our CRA. Our services include:
*identify and report significant adverse events to appropriatestaff
* ensure that safety reporting requirements have been met (e.g., IRB/IECsafetyreports, reconciliation of SAE reports with CRFs)
F.Investigational product review
Our CRAs ensure that your investigational product is being used properly according to protocol and the randomization scheme to subjects.
We also ensure about the storage of your investigational products
G.Queries and error correction
Our service in CRF Query Management for any protocol deviation during your trial.
H.Review of laboratory samples
Our CRAs ensure blood or other samples are to be collected
I.Study document file review
Our CRAs ensure that copies of all pertinent documents are available and filed. We make sure completeness investigator’s and sponsor’s study document file.
J.Monitoring visit report
Our CRAs summarize in details about their activities during the visit including any problems at the investigative site, what was done to solve them, or to make recommendations of action items for the next visit.
Adverse Events
Reporting to Ethics Committee/ IRB and Regulatory Authority
Monitoring of adverse events is one of the most important values in conducting clinical trial, for the protection of the subjects enrolled in the trial as well as protection of the patients and proper use of the drug once it is marketed. At the same time, safety reporting is one of the most difficult things for a study site to do correctly in proper time.
Prodia the CRO as extension of your team, provides you to review safety data throughout a trial by reporting adverse events that are serious, related, and unexpected to the Ethics Committee or regulatory authority within the expedited reporting time frames.
Drug Accountability
Drug accountability is the process and documentation by which we account the clinical supplies from the time of packing until use, return, or destruction.
As the importance of drug accountability in demonstrate that all subjects were given treatment by investigational products as planned in protocols, and in assess the efficacy and safety of the products in certain dosage. Prodia the CRO provides its service by records of documents shipment, receipts, dispositions, returns, and disposals of investigational products accordingly to GCP standards.
Study Site Closure
The final study is an extended monitoring visit provided by Prodia the CRO which will be checked accordingly and contains certain extra requirements.
1.To account for all drug supplies used and to collect all remaining unused drug supplies or to discuss appropriate destruction of unused supplies if appropriate.
2.To collect all other study supplies (unused case report forms, extra protocols, brochures, unused specimen containers etc.)
3.To review and collect final completed case report forms.
4.To complete documents of study file
5.To remind the investigator concerning his obligation to provide an appropriate clinical report if such has been specified, within the allotted time scale
6.To discuss as necessary, publication plans of the results of the study
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 its224 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) :
The first clinical laboratory in Indonesia with ISO 9001 & ISO 15189 standards
Member of National Committee for Clinical Laboratory System - NCCLS (USA)
Extensive internal quality control procedures (performed by Technical Quality Assurance Unit)
Extensive external quality control procedures (RCPA Quality Assurance Programs - Australasia, EQAS- Biorad, PNPME - Dept. of Health Republic of Indonesia)
Comprehensive quality assurance programs and compliance to GLP procedures
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)
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.
The clinical studies are performed in strict accordance with appropriate safety regulations and the Declaration of Helsinki.
Audit is a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), GCP, and the applicable regulatory requirements.
As a qualified CRO, Prodia the CRO has certified auditors who will be able to complete your needs in audits procedures to ensure that a site is complying the protocol in conducting a study including regulatory audit requirements. The audits service including the routine audits and for- cause audits. Audits will include but are not limited to:
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.
Biometric
Data Management and Data Analysis
• Data Collection • Data Verification • Data Storage • Data Analysis - Preparation of statistical analysis plans - Preparation of final statistical reports - Preparation of clinical study reports to ICH format.
Final Study Report
Because of the variety of compounds studies and the diversity of clinical studies undertaken, Prodia the CRO will help to review/edit the contents of the study report to ensure that all data are integrated and adequately handled.
Study Publication
Prodia the CRO will help to review/edit the contents of the report study and submits it for publication if requested.
Bioavailability and Bioequivalence Study
We will outsource bioavailability and bioequivalence service and pharmacokinetic studies to a professional vendor.
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