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CONTRACT RESEARCH ORGANIZATIONS
SABEQ supported Jordan’s pharmaceutical sector during the first three years of the program. This sector is robust and prominent within the region and is ready to graduate from SABEQ support. But the sector has spawned a promising subsector – contract research organizations that support pharmaceutical and biotech firms through conducting clinical trials and bioequivalence studies.
Strengthening Jordanian CROs enables the pharmaceutical industry to move up the value chain and expand beyond generics. Moreover, CROs that become internationally accredited and certified will be able to perform very high value export/research outsourcing work for international companies. Such export work will clearly demonstrate Jordan’s value proposition relative to the international knowledge economy.
SABEQ conducted a series of audits/gap analyses of the key CROs during Year 3 that indicated the many firms are near compliance with international standards. With targeted support these firms can achieve these standards and as a result they can attract very high value medical outsourcing work such as bioequivalence studies and clinical trials, by being more competitive in terms of cost and quality than other firms. For these reasons, while assistance to CROs may have limited direct economic benefits, the indirect impacts are likely to be substantial.
In order to take their place in the global market, Jordanian CROs must close several compliance gaps in infrastructure, technology and application of international standards. Specifically, SABEQ has identified the following areas for targeted support to the sector:
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Goal
Develop and upgrade Contract Research Organizations to world-class standards to integrate Jordanian enterprises into global value chains and facilitate the upgrading of Jordanian pharmaceutical manufacturers. |
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Targeted Results (Baselines to be established in first quarter 2010)
· Contribute to the creation of 20 direct jobs.
· Increase exports by 5% to $15 million by 2011.
· Attract $15 million in FDI and local investment by 2011. |
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Key Stakeholders
· Private sector: Jordanian CROs, JAPM
· Government: JFDA |
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Activities |
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1. Validation and Consultancy
· Improve CROs quality systems by processes consultancy and GxP compliance audits.
· Identify and adapt best practices of validation and qualification of computer systems, software and hardware within CROs to comply with International guidelines for GCP/GLP /ICH.
· Improve the traceability and accountability by streamlining CROs’ line operations and improving productivity. |
Key Deliverables
· Computerized Systems validation completed
· Laboratory Information Management System implemented
· Assessment & Gap Analysis for FDA, EU completed |
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2. Capacity Building and Mentorship
· Build capacity for CROs and related stakeholders in GCP/GLP
· Undertake Clinical Research Investigators/Monitors/ Associates Professionals Certification programs. |
Key Deliverables
· Advanced Training and certification Programs for Clinical Research Investigators and other target groups provided |
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3. Market Access & International Buyer-Seller Linkages
· Benchmark Jordan against other CRO markets and carry out extensive market research
· Facilitate CRO international buyer-seller linkages through Inward and Outward Trade Missions & Marketing & Promotional Toolkits.
· Work with BPO to promote CRO as KPO opportunity in Life Sciences vertical |
Key Deliverables
· Market entry guide
· Marketing materials created for the promotion of Jordanian CROs at international trade exhibitions and on inward-outward trade missions.
· Targeted marketing list created that identifies potential customers for Jordanian CROs and provides the baseline for direct marketing. |
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4. Legal and business environment
· Develop oversight capacity of Calibration requirements at the national level
· Create independent Institutional Review Boards (IRBs) in order to comply with GCP/ICH guidelines and Enhance legal environment and business approval process. |
Key Deliverables
· Calibration guidelines to assure compliance with International Guidelines of GCP/GLP adopted
· Institutional Review Boards Manual & SOPs developed
· BE Protocol approval and clinical studies process benchmark.
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By implementing these efforts, the sector can become a player in the international market and can become internationally accredited and recognized in key regulated markets.
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