We offer this service to big-pharma companies planning to recruit subjects in the countries of our business activities. Well-written protocol is arguably the most important factor for future trial success. A tremendous number of subsequent queries or protocol deviations can be avoided first place with good protocol wording and clear design. Sometimes, subject groups are distinguished with such subtle differences that recruitment problems are inevitable. Or initially suggested combinations of medical procedures during one visit are impractical or even impossible. And as it’s often the case, established local medical practice can have strong influence on the study protocol.

What we can offer is more clear heads to read through the protocol and model its practical implementation. During such review “bottle-neck” issues may be identified or corrective suggestions ensue. We can involve local opinion leaders for this activity, the same people who later may become your national country study coordinator.

For local investigators we also can offer our assistance in developing study protocols or protocol amendments. For example, investigators planning to carry out clinical research as part of their academic work may cooperate with us to fit their study protocol to local legislation and international regulations on clinical research in humans.

We can offer you access to our databases of sites and investigators for your initial contacts with sites. We can also provide our comments on site performance, possible issues and preceding history of successful cooperation. For different tasks at hand we can range suitable opinion leaders and make initial contacts with them on your behalf.

On your behalf we can contact local opinion leaders in the countries of our business activities. You may have different reasons for such contact: from scientific surveys and opinion polls, to protocol reviews and study feasibility interviews.

This may be part of protocol development or review service or a stand-alone service. We will focus your attention on current practice and local country specifics in order to make CRFs comprehensive, self-explanatory and containing all necessary information for your future scientific claims.

We can assist you in developing your protocol related questionnaires, forms, visual assessment scales (VASs), plans, charters, etc.

In the highly competitive environment of clinical trials today, it’s essential that your protocol, its design and procedures are of high priority in investigators’ current state of mind. With several protocols running at the same time at a study center, a protocol with the clearest design and comprehensive procedures often has the fastest enrollment with the least issues. To facilitate favorable protocol implementation we offer our service of training teams of investigators and/or CRAs on the protocol design or any its parts. This can be done as part of your GCP responsibilities for implementing and maintaining quality assurance initially before the study start or at any time during the study course, for example when essential amendments are implemented.

Should any situations arise that require your local representation with scientific or legal support in the countries of our business activities, we are ready to step in on your behalf.

During protocol submission review, regulatory authorities and/or ethics committees may request additional information and clarifications. On your behalf we can communicate with such bodies to respond to the emerged queries and resolve all possible issues.

Although many international pharma companies and CROs have their global study physicians on staff, we can offer you additional regional support. When it comes to safety physicians it’s the best to have a local employee familiar with local treatment protocols and current medical practices. We can help you identify and involve in your project a dedicated physician or a part-timer who will resolve safety-related issues. We can also assist you with submitting periodic safety reports to regulatory authorities.

If specifics of the protocol design require fast response to any unexpected situations, we can provide a round-the-clock support for your project team and study sites with information on protocol, IMP or any safety issues.

Protocol deviations during enrollment are costly and frustrating to all involved parties. To prevent them, we can review eligibility criteria of every potential subject before enrollment. With usual frequency of monitoring visits, it might take weeks and months for a monitor to get to the site and read through source documentation of any particular patient to verify subject’s eligibility. We will literally save you time and money by eliminating this kind of costly mistake on time.

To support eligibility criteria, confirm some adverse reactions or in other situations, all available medical information should be taken into consideration. That’s why we can, on your behalf, review and give expert assessment of any subject’s medical data, including:

• current clinical status and medical history;
• laboratory results, imaging conclusions and other supporting data;
• concomitant medication and its possible effects.

• Participation in Data Safety Monitoring Board (DSMB) and Independent Data Monitoring Committee (IDMC) meetings;
• Review of Periodic Safety Update Reports (PSURs) and DSURs;
• Review of Serious Adverse Events (SAEs) reconciliation information;
• Medical review of coding, listings;
• Clinical Study Report (CSR) review.

• Analysis of scientific medical literature;
• Pharmacoeconomics (risk/benefit analysis) for local health-care providers.