Global Clinical Connections

Contributed by:

Robin Robinson

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Building Relationship Bridges

Forming a winning CRO/sponsor partnership requires trust, communication, and understand ing the expectations and needs of the other party. Using advanced technology for communi cations, taking ownership, and getting to know your partner can ensure these elements are front and center of the relationship. GUTHRIE. XCELIENCE. Probably the single most important element required to form a solid partnership revolves around truly under standing the needs of both parties. With that in place, communications, decision points associated with successes and failures, and out comes become more logical. Clearly, these usually emerge from a great deal of upfront time or relationship experience before moving into a partnership arrangement. Any partner ship that mismatches capabilities versus needs can be doomed from the onset. GRIFFITH. APTUIT. Structured, transparent communications on both sides of the project are essential to a successful global partnership. This commitment to transparent communica tion should happen across various levels, such as: dedicating a project manager located in the specific market and time zone in which the client operates; maintaining a projectspecific Wiki that serves as a digital information repository; and holding daily conference calls and quarterly steering committee meetings. Each of these important communication com ponents avoids gaps in information that slow the decisionmaking process, as well as pro vides realtime access to and support for pro jects around the clock. For example, rather than simply providing a brief of the day’s activities, a Wiki can be created on a secure Intranet for each project. Staff members in North America can upload their lab notes, scan in useful documents, and write other comments about the project, creating a digital information repository that allows someone working on the project in, say, India to collab orate in real time. TYSON. CAMPBELL ALLIANCE. Trust is what it’s all about. For a sponsor and CRO to have a successful partnership, both sides need to establish trust: trust from the sponsor’s per spective that the CRO is providing the most appropriate staff and working as efficiently as possible to keep costs contained; and trust from the CRO’s standpoint that the vendor’s perspective is being considered and that the sponsor is not taking advantage of the part nership. PAGE. I3. There has to be transparency into the respective organizations with open com munications about resource capabilities and performance expectations. A solid global partnership requires trust, a complement of expertise, a true expectation of resourcing needs, and an understanding of regional dif ferences and their influence on the work to be completed. BY ROBIN ROBINSON Creating Global Clinical Connections A successful CRO/sponsor partnership is much like a marriage; it requires trust, communication,and a commitment to best practices by both parties. ccording to The Centre for Medicines Research International Ltd. in 2005 almost 50% of patients recruited for clinical trials came from outside of the eight core countries — Canada, France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. Both big pharmaceutical and smaller biotech companies are increasing their use of CROs to gain world penetration.Therefore, it’s more important than ever that all parties are on the same page and develop a model based on a true partnership. Expansion into emerging markets necessitates a high degree of global consistency and team integration between sponsor andCRO.Our Forum experts offer strategic and tactical advice for approaching the challenges in cultivating better relationships between CROS and sponsors in this situation. A 12 Ap r i l 2008 PharmaVOICE 0408 Layout FINAL MW 3/21/08 11:43 AM Page 12 GLOBAL connections HARTE. ETRIALS. The single most important element is trust — the feeling of having a partner that is operating in your best interest, contributing as a team member to offer advice and guidance, and participating as an active member of the team. GEATZ. INCLINIX. The single biggest challenge for a CRO is to understand the sponsor’s busi ness needs. This means knowing on a global basis what is technically — the protocol — and financially important to the sponsor. With the majority of pharmaceuti cals consumed in the United States, it makes little sense to focus on the rest of the world at the exclusion of the United States. Issues of timely enrollment at home remain the biggest challenge for sponsors, and this fact must be considered when going global in a trial. Coun try selections outside of the United States should be made with the sponsor’s compre hensive goals in mind. Those goals include geographic and ethnic diversity requirements, coupled with time to market and other finan cial issues. It is also vital to involve the CRO early in the process. The best time for CROs and sponsors to jointly construct their global strategy is when the technical requirements of the protocol are first known, not when the trial is behind schedule. The importance of involving partners in the early stages and giv ing them the chance to provide input into planning and accept and commit to their responsibilities in making the program a suc cess should not be underestimated. Strong col laboration from the beginning builds commit ment between partners, and that commitment yields success. HLINAK. INVENTIV CLINICAL. The key element for a solid global partnership — the delivery of DEBORAHBREWER.SeniorVP,Global Business Development,Omnicare Clinical Research,King Of Prussia, Pa.; Omnicare Clinical Research is a Phase I to IV contract research organization serving the biopharmaceutical and medicaldevice industries. For more information, visit JOHN FARINACCI.CEO,ResearchPoint, Austin,Texas; ResearchPoint is a fullservice, global CRO.For more information, visit J.TOBIN GEATZ.President and CEO, Inclinix Inc.,Wilmington,N.C.; Inclinix is an enrollment CRO and resource for clinicaltrial recruitment solutions. For more information, visit MICHAEL A.GRIFFITH.CEO,Aptuit Inc., Greenwich,Conn.;Aptuit focuses on streamlining and supporting the drug development process.For more information, visit RANDALLH.GUTHRIE.VP,Xcelience,Tampa, Fla.; Xcelience is a CRO providing drug development services for the pharmaceutical industry. For more information, visit MICHAEL HARTE. Senior VP, Global Strategic Accounts, etrials Worldwide, Morrisville, N.C.; etrials is an eclinical software and services company enabling pharmaceutical, biotechnology, and contract research organizations to bring new drugs to market.For more information, visit MICHAEL HLINAK.President and CEO, inVentiv Clinical Solutions, Houston; inVentiv Clinical Solutions provides flexible, scalable clinical development solutions, including trial management,monitoring,data management, statistics, medical writing, regulatory, and clinical staffing/resourcing. For more information, visit NIGEL PAGE.President, i3 Research, Basking Ridge,N.J.; i3 Research,an Ingenix company, is a fullservice, therapeutically focused,global CRO providing integrated scientific strategies throughout the pharmaceutical product life cycle. For more information, visit GARYTYSON.SeniorVP,Clinical Development Practice, Campbell Alliance, Raleigh, N.C.; Campbell Alliance is a management consulting firm specializing in the pharmaceutical and biotechnology industries. For more information, visit JOSEFVON RICKENBACH. CEO,Parexel International Corp.,Waltham,Mass.; Parexel is a global bio/pharmaceutical services organization that provides knowledgebased clinical research, medical communications,and consulting services worldwide.For more information, visit Thought Leaders THE SINGLE MOST IMPORTANT ELEMENT REQUIRED IN ANY PARTNERSHIP IS GENUINE COMMITMENT. For expectations to be met on both sides, there must be a true intention to form and maintain a global partnership with recognition that there is mutual dependency. Josef von Rickenbach.PAREXEL 13 PharmaVOICE Ap r i l 2 008 0408 Layout FINAL MW 3/21/08 11:43 AM Page 13 GLOBAL connections clinical services on a global or offshore basis — must be based on common ownership, all or in part, of the CRO and the global delivery plat forms. This allows for consistent and con trolled services in a more effective way than when the relationship between the domestic CRO and its global partners are mere alliances. BREWER. OMNICARE. An ongoing commit ment between the partner companies to grow the relationship within an organizational and cultural framework will create an environment of success. A focus on creating longterm value for all stakeholders will help strengthen the commitment. VON RICKENBACH. PAREXEL. The single most important element required in any part nership is genuine commitment. For expecta tions to be met on both sides, there must be a true intention to form and maintain a global partnership with recognition that there is mutual dependency. FARINACCI. RESEARCHPOINT. Quite simply, partnerships need leadership. Whether it is a project that is regional, and/or global in nature, a leader must call upon all of his or her experi ence and skills to manage the global diversity of regulatory requirements, culture, language, and time zones encountered with global devel opment to deliver a highquality product. Defining the Relationship Elements Contracts, ontheground research, and teaming up with likeminded partners can help facilitate the trust and communication needed to ensure a successful partnership. Other important factors include implementingcorporate liaisons, identify ing responsibilities, and outlining expectations and goals. GRIFFITH. APTUIT. Beyond optimizing com munications across the project and assigning a single project manager to orchestrate all of the work globally, another significant considera tion is the establishment of a single contract that is enforceable in the United States for all work globally, thereby effectively addressing many intellectual property concerns while working in other regulatory regimes. Addi tionally, when a pharma or biotech company partners with a contract organization to con duct global work, the sponsor must be involved in project organization as much if not more than the contract organization by having internal corporate liaisons that can rapidly be contacted should issues or obstacles arise. Facilities and teams should be inherently designed for successful global collaboration. When partners are fully engaged on all aspects of a project and organize internally to support active and timely communication, delays at decisionmaking interfaces that consistently plague traditional drug development can be greatly reduced. TYSON. CAMPBELL ALLIANCE. There are three keys to establishing the type of trust necessary to ensure an effective global partnership. The first is to clearly define contractual relation ships, which include pricing but go beyond pricing and include explicit servicelevel expectations for both sides of the agreement. The second is to have excellent, ongoing communications at both the project and the relationship levels. This allows issues to sur face before they jeopardize or break that trust. The third is commitment to the relationship on both sides to ensure that when issues are inevitably identified, both sides are commit ted to working them out rather than looking outside the partnership. PAGE. I3. Understanding of the standard of care for each therapeutic area within the region is a huge step toward a successful out come. This can easily be achieved by using on theground expertise within each region and a flexible global project team model that com plements the sponsor’s needs. Also helpful is a governance structure that incorporates a shared vision and joint ownership of the goals and overall success of the partnership. To keep partners on the same page at all times, visibil ity of the future work stream to enable proac tive identification of resource needs at the human, geographic and/or technology level works well. This leads to more open commu nication and innovative vision focusing on solving issues in a collaborative manner. GEATZ. INCLINIX.Though the idea that a single CRO can serve every need in a global trial looks good on paper, this scenario is rarely the case. Therefore, specialty CROs and other sup pliers are needed. It is important that all of these entities focus on the needs of the sponsor as outlined in the protocol and sponsor’s busi ness practices. Sponsors must be able to trust that their CROs understand the unique nuances from the regulatory perspective, cul tural perspective, and beyond, and will share that information to help drive timely imple mentation in each country. HLINAK. INVENTIV CLINICAL. Global presence, solid financial footing, knowledge of each country’s particular characteristics, ability to deliver or develop a customized solution spe ONEOFTHE BIGGEST CHALLENGES IS MAINTAINING A DEDICATIONTOTHE RELATIONSHIP. It takes work and commitment to roles and responsibilities from the top management down to individual project teams. Deborah Brewer. OMNICARE TRIALS IN COUNTRIESWITHVARIOUS ORNO STANDARD OF CARE MUST BE CAREFULLY MANAGED; the major issue is to guarantee the patient’s rights to a standard of care and ensure follow up through local public health systems. Michael Hlinak. INVENTIV CLINICAL 14 Ap r i l 2008 PharmaVOICE 0408 Layout FINAL MW 3/21/08 11:43 AM Page 14 QUESTIONS ABOUT YOUR BRAND CAN BE TROUBLESOME. SO CAN THE WRONG ANSWERS. Customer safety, company reputation — there’s a lot at stake in Medical Affairs. You need to hire people you can trust. That’s why you should call SOS. A leader in outsourced Medical Communications Services, SOS functions seamlessly as your company’s Medical Affairs Department. Our qualified healthcare professionals provide expertise in a range of areas: Call Center, Drug Safety, Medical Meeting Support, and Medical Writing. LET SOS BE YOUR COMPANY’S VOICE. Contact Evan Demestihas, M.D., or Beth Price at 7706939300, or visit our website. www . med i c a l a f f a i r s . c om The Scientific Basis for Commercial Success How long does the drug remain in your system? I am experiencing a side effect! What should I do? Is my medication glutenfree? Has this product been studied in _______? Is this product ABrated? What is the recommended dosing? Can this product be used in pediatrics? Which clinical studies are available? Is there someone at your company that can discuss offlabel use? Can this medicine be crushed or cut in half? Can you conduct a literature search for this unapproved indication? How long is the medication stable once the vial is punctured? Is it OK to take this on an empty stomach? What is the shelf life? other products on the market? How should this medication be stored? Is this product approved? What should I do? What is the recommended storage condition? Can this product be used in pediatrics? What data do you have supporting the efficacy of this product? 16 Ap r i l 2008 PharmaVOICE cific to the client’s needs, and demonstrated delivery capabilities — in other words, a good track record — are pivotal. BREWER. OMNICARE. The partners must have common values as well as shared goals. There must be a good cultural fit with a synergy of corporate visions, missions, and a longterm philosophy for success. Keeping the Partnership onTrack Like marriages,evenpartnerships formedwiththe best intentions are fraught with challenges that continuallyneed tobemetandovercome.Lack of commitment, lack of communication,andmisun derstandings between parties can put the out comeofmanypartnershipsat severerisk.Thevul nerabilities of the relationships canbeconquered, however, through planning,consistent communi cation, keeping models simple, and maintaining realistic expectations. GRIFFITH. APTUIT. The major challenge that any drug development project faces is misunderstanding of, or gaps in, informa tion. Contractors need a wholepicture perspective of the project and be well con nected with the client to ensure success of the overall program. If a project has to be stopped to clarify a component of the pro ject or to have the client make a decision on an issue that was not anticipated, it slows the project down, incurring further cost and risking the rescheduling of pro duction slots. CROs should plan for all aspects of a project, whether they are tasked with every aspect or not. A solid understanding of where a client’s project has been and where it’s going can help. Having an intimate working knowledge of the entire process and the sponsors’ pro jects makes it easier to make decisions that will maximize time and investment. TYSON. CAMPBELL ALLIANCE. The risks are manyfold. One risk from the sponsor side includes choosing the wrong CRO; not all CRO affiliates around the globe are equal ly qualified or committed as expected in the contract. Or the CRO may lose inter est in the partnership after it launches and fail to commit the resources necessary. On the CRO side, the sponsor may not truly communicate its partnership relationship to all its staff, or the CROmay find itself in a sit uation where the sponsor continues to treat the CRO as a vendor rather than as a strategic partner. Some sponsors may jeopardize the partnership by not investing in the communi cation and management effort necessary to maintain the partnership. HARTE. ETRIALS.The risks and challenges that inhibit a relationship occur when key deci sions are not made, and when surprises occur that impact endpoints, duration of study, and overall team performance and delivery. Whether projects are outsourced or in sourced, this leads to change orders, missed timelines, and overall failure of delivery. Preparing to face or alleviate these issues can go a long way toward minimizing or avoiding them, especially when using technologies that provide a comprehensive view of clinicaltrial data and therefore a means for faster decision making. Technology is available that can instantly track patients, recognize screen fail ure causes, locate unproductive or untrained sites, recognize a certain stratum that needs emphasis, and monitor staff member or CRO activity within the system. With today’s tech nologies, especially those integrating the vari ous pieces to simplify the collection, cleaning, and analysis of study data, these data are read ily available and enable much greater control of study activity. GUTHRIE. XCELIENCE. We work in an industry where changes can occur overnight. Priorities shift, development plans change, and let’s face it, drug candidates die. Through all this we continue to strive for relationships that can cre ate winwin for all parties in the face of change. From a CRO perspective, maintaining a solid portfolio of different types of relationships is essential. On one end of the spectrum, partner ships are a very sophisticated outsourcing model, but they come with risk. For the CRO, maintaining strong relationships that follow a more simplistic outsourcing model helps miti gate the potential risk associated with the more complex model found in partnerships. PAGE. I3. There are myriad risks with every partnership, ranging from redundant project team members causing confusion over the responsibility for the tasks within a resource or a region to poor communication pathways that may impact decision making and issue resolution. Challenges such as a poor workflow and inadequate processes can hinder the suc cess of the relationship, as can poor logistics planning for drug supplies, electronic system requirements, and the like. In global projects incorporating affiliates, a weak global leader creates the risk of losing control to the region al entities. Another major problem can occur if there is a lack of understanding of the stan dard of care in the region in which the trial is to be conducted. Synergy between parties can be undermined by micromanagement of the CRO or inflexibility in company processes or company personnel. All of these potential issues can be averted with proper planning, allowing adequate time to develop the execu tion plan for the project and incorporating cer tain failsafe elements, such as ensuring the project team is set up from a global perspec tive with the sponsor and making sure roles and expectations of performance are discussed and agreed upon up front. Each country needs to be allowed enough time to get up and run PROBABLYTHE SINGLE MOST IMPORTANT ELEMENT REQUIRED to form a solid partnership revolves around truly understanding the needs of both parties. Randall Guthrie. XCELIENCE 0408 Layout FINAL MW 3/21/08 11:43 AM Page 16

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