International Life Sciences Awards 2017

26 GHP / International Life Sciences Awards 2017 , LI170020 RD CONNECT is named to reflect the value it aims to bring to its industry clients by ensuring the challenges that occur during research and development still result in the successful outcome of a project. Caroline discusses what services the firm provides as well as the usual clientele the company deals with. “Historically, RD CONNECT has carried out for different clients a subset or many of the operational and clinical science tasks required to successfully perform a trial tasks, with the exception of formal data management programming and statistical programming and analysis. Clients, classically, have been pharma or diagnostics companies whereas a relatively small percentage of clients have been service companies. There is great satisfaction in seeing a project through to successful completion for those involved at all levels of trial conduct. Previous experience has shown how important it is to prepare well the groundwork for a trial; this will help to prevent delays or serious problems.” Commenting on her unique background, Caroline highlights how her experience is slightly different from others within the industry. Keen to point out that she enjoys customer interaction, Caroline believes relationship Best Clinical Trials Project Management Company - UK RDCONNECT Ltd is a small clinical trials projectmanagement company, which to date has focused on the areas of regulatorymedical writing and clinical trial operations, including some clinical scientificwork.We invited CarolineHardwicke to tell usmore about the firmand the secrets behind its success. and communication skills are key to the completion of a good study or project. “My experience has traversed clinical operations, clinical science and also programme management across a variety of therapeutic areas. Roles interfacing with client companies and/or investigative sites and staff can be very stimulating and enjoyable. In my view, good relationships and good communication with the client and research sites are vital when managing studies. These have been often mentioned, but without good interactions with the other players in a project, you cannot obtain optimal data and hence, results, especially when there are pressured deadlines. I have been fortunate to work with some delightful people in both industry and academia. Although needing to respect the relevant GCP and other guidelines of course, it is important to make the paths of research and data collection flow smoothly.” Looking forward, the firm has shifted its focus to the subset of operations regarding data quality. As company principal, Caroline observes how the company plans to achieve its overall mission, citing attention to detail as vital to providing good quality, interpretable data to clients. “More recently, the focus of RD CONNECT has shifted to RBM, data review and audit. The company mission is to provide good quality, interpretable data to its clients from clinical research and academia. Longstanding experience has shown me that knowing the details from study operations and data collection and review processes is vital to the generation of clinical data which are of a standard sufficient for regulatory use and acceptance. This is a service that can be offered to the academics, and particularly pharmaceutical sponsors or to CROs.” Within the wider life sciences space, Caroline tells us what developments she foresees and notes how RD CONNECT will adapt to the changing environment. In an increasingly technology orientated industry, the firm seems well placed to adapt and evolve as a company, though Caroline does mention that there may be a need to adapt by employing new software in some circumstances. “Biomarkers and their predictive value for diseases and response to targeted treatments have been an expanding area of research, especially with the current and ever-widening knowledge of chemical mediators and their involvement in disease genesis. Clearly, there are increasingly more targeted products in clinical development and likewise, with more sophisticated diagnostic techniques, and continued interest in the chemical disease Contact: Caroline Hardwicke Address: RD Connect Ltd 17 Mascotte Rd, London, SW15 1NN, United Kingdom. Telephone: 07876 775215 cascades and pathways, consequent clinical benefit. Gene therapy and understanding the microbiome are other promising areas. RD CONNECT should be able to function with these anticipated evolutions in treatment choices, without major change to its data review methods at this time. With more sophisticated analytical and approaches, however, we may need to adapt to employ updated software for such review.”