India's potential attractiveness for clinical research has encouraged the growth of contract research organizations (CRO). However, Indian sponsors are still cautious about outsourcing the clinical trial activity to CROs. Recently, there have been reports of sponsor and CRO blaming each other for failure of products by international agencies.

These events have cast a doubt on sponsor-CRO relationship. In India, the tendency of sponsors has been to treat a CRO as one more service provider. On the other hand, many CROs have entered the fray, without realizing their responsibilities for a sponsor's project. There is a need for developing a healthy relationship between the sponsor and the CRO. This article reviews the approach for a harmonious relationship between the sponsor and the CRO.

Selection of a CRO

For a sponsor, the relationship starts with the selection of a CRO. Critical considerations in choosing a CRO are:

Commercial

Today most clinical trial projects last for several years. One of the major concerns for a sponsor is financial viability of the CRO. The sponsor would like to assure himself that the group backing CRO understands the business needs and has long term plans for investment and growth. One key issue is whether the CRO belongs a company with conflict of interest in the sponsor's area of operations.

Capability & Credibility

The CRO team's capability is based in the experience of running trials in diverse therapeutic areas and in different phases. The experience of the team in managing GCP trials and an established system of training in therapeutic areas, in the regulatory guidelines, in GCP, in functional areas are key considerations in assessing the credibility and capability of the CRO.

Besides, having broad scientific, medical, and technical expertise will make a CRO capable of providing creative solutions. A demonstrated track record of CRO management's commitment to quality and time lines are important considerations for a sponsor.

Compliance

The CRO should have a team, which has understanding of global regulations. They should have systems for compliance with global practices. Establishment of quality systems and process are vital in considering a CRO. Another major consideration is a CRO's compliance to maintaining confidentiality of sponsor's proprietary information.

Capacity

The CRO should be able to expand with changing needs. The CRO is now considered a ` solution provider'. A CRO who can deal with uncertainties and is willing to handle additional assignments boosts confidence in the sponsor.

Establishing Relationship

The sponsor-CRO relationship is based in acceptance and allocation of key responsibilities for all clinical trial tasks. This needs to be defined in a well-written task ownership matrix (TOM). ICH-GCP 5.2 defines this relationship quite succinctly.

Good Partnership Practice

After defining the TOM, the sponsor has to realize that CRO is more like a partner than a supplier. The process needs to be strengthened by developing a joint working relationship.

The GPP requires:
- Establishing measurable goals and objectives
- Education of the CRO team on the expectations of quality and timelines of the project
- Expectation management by regular transparent communication
- Enforcement of the accepted norms and goals
- Mutual respect and willingness to learn from one another
- Regular performance measurement and feedback
- Open communication and conflict resolution process
- Systematic Progress review process

The tendency in Indian sponsor is to manage CRO relationship through one junior operations manager. It is essential that the senior management is involved in the process and is supportive of the outsourcing plan. There is also a need, for both sponsor and CRO, to establish regular interaction at multiple responsive levels in their organizations.

For a sponsor the trial is a vital tool to nurture his new product and when he hand over this task to a CRO, he is anxious and concerned like a biological patent. The CRO, in turn, has to accept this roles and responsibilities like a foster parent! The key to harmonious relationship both sponsor and CRO is to be trans-parent!

- The authors Dr Arun Bhatt is president & Dr Umakanta Sahoo, project manager at ClinInvent Research Pvt Ltd