Choosing a partner

Choosing the right solution provider is always high on the agenda for many pharmaceutical companies. Sachin Jagdale reports on norms and requirements of this procedure

CROs have long been important growth partners of pharmacetuical companies. Trust and economics are the two major deciding factors that influence this decision . While CROs try their best to win contracts from pharma companies, pharma decision makers engage themselves in selecting the right service provider. Though trust and investment occupy the top spot on the priority list of pharma companies, they do have many other things to sort out while selecting the right service provider as business partner.

Pre'Size' story

Very often size of the CRO is the first thing that would impress the client. It is commonly assumed fact that big size CRO is an indication of the growth and the number of jobs CRO gets. However does size really matter? And where does quality and experience stand?

Anuradha Acharya, CEO, Ocimum Biosolutions, says, "The size of the CRO matters, but not with a clear proportionality of "larger the better". As an organisation, making a choice for a CRO, size in itself cannot be the deciding or limiting factor - it depends on the specific services being sought out. In some cases the depth of a small CRO focused on a very niche area is required and in other cases, the width, range and reach of a larger CRO will best fit the requirements. Just because a CRO is large they are not going to deliver quality, if they grew too soon too quickly. So the best approach, is to not get hung up purely on size." At Ocimum Biosolutions, for example, the company provides in-depth gene expression studies and genomic solutions, yet their services span the entire discovery process chain. In such a model, in fact, it is hard to classify the company as niche or overarching, large or small instead it is best to evaluate a CRO in the context of client's needs and the CRO's capabilities.

According to Sujan Dhar, CEO, Abexome Biosciences, a CRO must have a critical size in terms of the facility, analytical instruments, trained manpower and for clinical CRO's access to multiple sites etc. A critical size will enable the CRO to take up different kinds of projects without sub-contracting major components of it. Once the critical size is achieved, a CRO may require to scale up more number of projects. However, such expansion is purely scale and investment driven.

Sometimes a CRO is scattered across different parts of the country in the form of small units. That CRO may be capable of introducing big set up at one place but the nature of the service sometimes make the organisation set the base at various places. Expressing his personal views, which may not tally with those of the company, Anand Bidarkar, Vice President, business development, Siro Clinpharm, opines, "The size of a CRO is an important consideration while planning to outsource a clinical study. For a country like India size is very important in terms of reach to sites distributed across various states. For example when we had to conduct a complex study involving an immunoglobulin, it was not possible to find the sites with the level of expertise required to carry out this study in a single state or for that matter a single region. We had to reach out across India to select the 15 sites across seven states, required for the study. Our size was a very important factor in facilitating our reach."

He adds, "A large sized CRO is often able to negotiate better rates with vendors, travel agents and command greater attention and interest of the investigators. This is because of the repeat work and the continued business value that they bring to the table in any negotiation. Smaller sponsor companies planning to conduct studies that require a high level of expertise or participation by "in demand" investigators could benefit by working with a large sized CRO. These companies often have problems in attracting the most potential investigators, The brand image and the negotiating power of a large CRO can be a significant value addition in ensuring a successful trial conduct for these companies."

According Mahesh Malneedi,CEO, MakroCare, a CRO is a dynamic bridge between the sponsor and the principal investigator. They help the sponsor in different fields of clinical research like Medical writing, Clinical operations, Pharmacovigilence, Data management and many more. Each CRO has its own specialised fields of works but in general it will render all the activity to the sponsor.

Malneedi asserts, "Sizes of a CRO will not matter to the sponsor as long itsperformance is the best and time bound and following all ethical issue of human research. The main indicators for a CRO will be the deliverables in the given time lines of the sponsor. As we say, experience is a costly teacher but the best teacher a CRO will get is the experience of executing all different types of trials beginning from Phase I to Phase IV and many more. Any CRO develops based on the projects they have and the entrepreneurship qualities of the management of that CRO."

Prahlad Tayade, DGM Contract Research Raptakos Brett, points out, "Size of the CRO should not matter whether big or small. Intellectual capability and strengths are the internal beauty of the CRO and machines are external beauty of CRO. There should be the balance of both."

Expectations from CRO

"Strong expertise in area of interest, demonstrated experience, a motivated trustworthy team, stringent project management, certified quality systems and most importantly right pricing are some of the expectations from any CRO," reveals Acharya.

Hemant Mondkar, Vice President, Indian Pharmaceutical Association (IPA) (Maharashtra State Branch), echoes some of Acharya's views. According to him, a CRO must have the requisite expertise and experience in the domain area where the services are to be out sourced . Concerned organisation must fulfill company's corporate requirements in terms of strategic fit in terms of company's policy and must pass technical due dilligence. Excellent track record of service, deliverability in terms of time, quality, compliance to regulatory requirements (compliance history) and good traceability and support of documentation are also very crucial things expected from your solution provider. Business integrity in terms of confidentiality of information is expected from the business partner..

Mantra of successful partnership

Long lasting partnerships are built not through agreement but through uncompromised service. "Be it depth of analysis, data quality, adherence to timelines or customer support, we do our best to establish trust in our capability and provide a hassle-free experience to our clients that most partnerships become long-term more out of volition than through a contractual obligation," says Acharya revealing her success mantra.

The primary objective of a CRO should be to contribute positively to the business of its sponsors. Abexome strongly believes that a sponsor is outsourcing a job to them because he trusts in their quality, integrity and speed. Dhar opines, "There have been a few cases where something went wrong. However, in each case we were very transparent with the sponsor on what went wrong and focused on creating a solution rather than playing blame-games. In most of the cases this worked to strengthen the relationship."

According to Bidarkar, the basis of a long lasting partnership is developing a synergy with the sponsors interests. This requires moving away from the transactional model and exploring areas in which a sustainable partnership can be developed. "We are fully aligned with the clinical pipelines of our long term partners and often develop capabilities and infrastructure ahead of the curve. In short, we would act as an extended arm of their company and are ready when they need us. This calls for an appetite for some risk and investment in anticipation," informs Bidarkar.

Malneedi feels that the advantage of a CRO is that the sponsor will be free of some responsibilities and will also economically benefit and can concentrate of the R&D process of the company. Speaking on the ethical issues Malneedi says, "Building confidence and delivering according to the time lines and following good standard of ethics will have a great impact on this relationship."

Division of work

Many factors determine the allocation of work to any particular CRO or CROs, size of the job, deadline and ability of CRO to handle the task are some of those. Many times requirement of the patients would also vary. In order to reach such populations it becomes necessary to operate in more than one region. Malneedi says, " Increasingly, access to different types of patient populations, specific study measurements and different kinds of expertise will require that a clinical trial project is to be outsourced to more than vendor in order to reach faster timelines comparable to hiring all the services to one CRO. Multiple activities that encompass during the execution of a clinical drug development can be outsourced to dedicated different vendors. Together these vendors can provide expertise, experience, and capabilities that would be difficult to assemble in a full service CRO or that might exist but be occupied with other priority projects in a CRO." Every business revolves around the cost factor. So does the philosophy 'Think small, save big' while selecting a CRO come into play in some cases? Mondkar has the final word saying, , "Cost is an important factor in the decision to outsource , however cost must not be the sole criteria. Other factors such as meeting the client compliance requirements and cost becomes a competive advantage. then think small, save big can be considered. Not the other way round."

sachin.jagdale@expressindia.com