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What to expect from a CRO


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What to expect from a CRO

  1. 1. Pharma Bio World August 2013  19 What to Expect from a CRO? T he title of this article begs another question first. Why a do we need a CRO (Contract Research Organisation) for drug development, is it essential? All pharmaceutical firms including large MNCs require assistance from CROs to expedite development of a new drug or product to reduce costs and in most cases to exploit CROs domain expertise. CROs also provide the variety and number of investigational sites with the required training and qualifications that the investigators ought to have. Large biotech companies have such complex and back and forth development processes that it pre-requisites a CRO’s support in product characterisation and clinical testing at numerous stages. The mid and small sized pharma companies often do not have either a full-fledged pre-clinical and clinical R&D or the generic pipeline is too huge to be handled on their own. Thus in addition to provide expertise, knowledge, equipments and facilities, CROs can share the responsibilities (by means of transferred authority) of drug development with favourable timelines and regulatory assistance. There are, however, potential risks involved in all outsourced works to CROs. Other than losing direct control of the projects, there are risks of poor or irrelevant data generated, GXP violations, fraudulent conduct of study and missed timelines. Poor communication and relational dissatisfaction could be other hassles involved in outsourcing. There are organisations who have thoroughly and quantitatively surveyed the various areas of sponsor expectations and whether various CROs meet them or not. Such surveys provide very interesting data that can help strategic alliance and relationship management between sponsor companies and CROs.1 The author of this article has mainly alluded to his experiential qualitative data in writing this article. Twofold Relationship: Contract and Trust Contracts define the legal and task obligations of a CRO that is expected by the sponsor. Thus, the practical and commercial aspects of the relationship between the sponsor and the CRO revolve around what has been clearly embodied and appended in the contract. Anything that is not clearly written in the contract as a deliverable by the CRO, will be treated as a non responsibility of the latter in a court of law. In fact one of the first things to be expected from a CRO is a contract that is clear and unambiguous in terms of deliverable and has been written in good faith. The wholesome and long standing relationship between these two entities, however, cannot be entirely contractual in nature. It is actually based on mutual trust as any good relationship is. Trust in and of what? The sponsor trusts that a CRO will deliver quality studies and data as mentioned in the contract within the stipulated timeline. In return, the CRO trusts that the sponsors will co-operate with all necessary information, especially thorough objectives and study protocols, make milestone and final payments on time and will not micro manage their projects while being conducted by the CRO. Asherman and Sagotsky have looked into the potent role of trust in successful to “best” sponsor-CRO relationships.2 Effective communication plans should be evolved such that detail processes for discussing performance expectations, releasing undue pressures and for escalation of Dr Bhaswat S Chakraborty Sr Vice President Research & Development Cadila Pharmaceuticals Ltd “ “ Anything that is not clearly written in the contract as a deliverable by the CRO, will be treated as a non responsibility of the latter in a court of law. What to Expect from a CRO 19-21.indd 19What to Expect from a CRO 19-21.indd 19 8/21/2013 11:54:01 AM8/21/2013 11:54:01 AM
  2. 2. Pharma Bio World20 August 2013 Understanding the continuum is likely to enhance the satisfaction at all levels. Gains in delivery- and other critical project-timelines constitute the most discernible improvement in efficiency. Improved timelines are best appreciated when the budget and the scope of the project have not been changed disfavourably for the sponsor. Improved efficiency over time with monitoring of the CRO activities is a positive sign of a successful sponsor- CRO relationship. This also eliminates micro-management of the CRO which often poisons the relationship. Clarity of all milestone activities and the scope of data analysis should be understood by the CRO such that all supervisory or issues through the governance structure are practised honestly. Expect Value, Quality, Guidance and Satisfaction No matter how genuine the long term relationship between a sponsor and a CRO is, the latter is ethically and legally bound to deliver value and quality in conducting studies. Value in this context is benchmarked science, following the appropriate guidelines, GXP compliance and timely delivery of projects. The quality is the integrity and accuracy of the data. The quality applies to both valid in- process and analysed data, and its correct interpretation in the reports prepared. Reports must be in the regulatory friendly formats (eg, CTD). The major expectations and underlying needs met provide the level of expectation that the service receiving sponsor will experience (Figure 1). The Efficiency Continuum: Meeting Timelines within Scope & Budget Efficiency is a multi-significant term but is mainly used for timeline, supervision and process improvements. Efficiency is also a continuum rather than being discrete, arbitrary numbers on a scale. review elements are exactly known by the latter. This will reduce overseeing and duplication dramatically. Many CROs may specialise in process improvement which may culminate into generation of intellectual property rights. The exact duration of relationship that will lead to improved process efficiency is rather difficult to predict as it depends on a multitude of factors. Regulatory Compliance Except for a very small percentage of the projects, all activities outsourced to CROs are expected to follow applicable regulatory requirements. The good practices including GMP, GLP and GCP must be in compliance with following mutually agreed upon SOPs. QA and QC must be vigilant and assuring to the sponsor. In addition to championing the compliance with GXPs and other regulatory requirements, all sponsors expect that the CRO, that they have outsourced to, will be able to quickly receive a local trial or manufacturing license. The CROs are also expected to know the nuances of the local regulatory agencies in terms of pre-requisite data and the time required for receiving the approval for trial conduct in details. The performance standards of regulatory agencies are different in various countries. Slower approval times warrant a better planning and preparation for the projects. Figure 1: Schematic representation of the satisfaction gained by the sponsors when their needs are met at different levels and cumulatively. Table 1: Top 10 Expectations from a CRO 1. Competitive cost or clear cost advantage & adherence to budget 2. Timelines management within defined scope and budget for the project 3. Quality control and quality assurance 4. Regulatory compliance & strategic advice 5. Documentation in standard (international) formats 6. Low attrition rate of CRO personnel 7. Availability of adequate number of personnel in all pertinent areas 8. Involvement/intervention of senior management whenever necessary 9. Scientific and technical advice 10. Customer satisfaction assurance, metrics of satisfaction What to Expect from a CRO 19-21.indd 20What to Expect from a CRO 19-21.indd 20 8/21/2013 11:56:58 AM8/21/2013 11:56:58 AM
  3. 3. Pharma Bio World August 2013  21 a partner CRO. However, this is not the general reality. The heart of the problem lies in the lack of an effective implementation of the partnership programme. Frequently, the drive to save resources and costs that led to strategic partnering in the first place inhibits upfront investment in the relationships. For example, while it is acknowledged that frequent communication, face to face meetings, and training programs contribute to the success of implementation of strategic relationships, pressure to conserve costs often prevent these from taking place.1 Conclusions We have examined the nature and levels of expectations that a sponsor pharmaceutical or Biotech Company or any other relevant entity may have from a contract research organisation. The expectations are based on mainly three parameters, namely, scientifically accurate conduct of the project, regulatory compliance and meeting the success metrics in terms of time, scope and budget. The experiential data and published surveys point out that the relationship between the CRO and a sponsor must be based on honest faith, transparent and well written contract and mutual cooperation. The levels of satisfaction gained by the sponsor will depend not only on the selection of the correct CRO but also on meeting mutual goals, promises and milestones and on excellence of communication. References 1. The AVOCA Group (2010). 2010 Avoca Report Executive Summary. http://www2. reports/2010-avoca-report-executive-summary 2. Asherman IG, Sagotsky B. (2009). Trust- Based Influence and the Sponsor/CRO Relationship. The Monitor (Association of Clinical Research Professional Journal), August 2009: 35-39. 3. Applied Clinical Trials Online (2013). 9th Annual Avoca Industry Survey Results. appliedclinicaltrials/article/articleDetail. jsp?id=807740 Contact: Learning Together: Mutual Respect This article would be incomplete if mutuality of responsibilities and roles is not mentioned even though the theme of this article is kind of unidirectional (sponsors expectation of CRO). As mentioned in the previous paragraph, successful delivery of a project is not only the CROs’ responsibility it is also an accountability of the sponsor. How so? Firstly, trust, respect and learning together will bring the members of the sponsor and the CRO team together. Finally, in last two decades or so, many refinements came through mutual discussion and subsequent joint designing of the projects by the aforementioned two stakeholders. Expectations that Lead to Success Table 1 enlists the main expectations that need to be met for successful CRO projects leading to at least an appropriate regulatory submission. At all stages of a project or multiple projects, robust systems for measuring performance and relationship are very important. Particularly important are metrics that reflect status in an ongoing manner and that are therefore actionable during the course of a study.3 Successfully Met Expectations In a survey conducted by Avoca group, it was found that nearly half of the sponsors had strategically entered into partnership with CROs. The most common objectives for launching these partnerships included reduced costs, improved quality, improved efficiency in use of internal staff, access to operational expertise, and process improvement. Among sponsor respondents whose relationships spanned a period of more than 3 years, there was considerable variability in whether expectations in each of these areas were met, and in the time it took. For example, over half of the respondents achieved cost savings in one year or less, although, about a quarter reported never achieving cost savings. Additionally, about half of the sponsors achieved improved quality within one year; however, nearly 20 per cent reported never achieving this. Similarly, process and efficiency improvements were attained by a little more than one third of the respondents.3 Unmet Expectations It has been observed that in poorly performing strategic relationships, the sponsor management is convinced that they simply made the wrong choice of“ “ Successful delivery of a project is not only the CROs’ responsibility it is also an accountability of the sponsor. What to Expect from a CRO 19-21.indd 21What to Expect from a CRO 19-21.indd 21 8/21/2013 11:57:31 AM8/21/2013 11:57:31 AM