Surveys and Observational Studies

Beyond the evidence standards set by traditional clinical trials, well-designed and implemented surveys and observational studies can help you, your patients, regulators, and prescribers understand the real-world use, value, and safety of your products. Observational studies are also increasingly important for reimbursement decisions in both the US and many European countries as risks and benefits, patient-centricity, and comparative effectiveness continue to be the driving themes within the industry.

Grounded in science and supported by state-of-the-art technology, we can help you develop real-world evidence through a variety of study types—surveys, cross-sectional or longitudinal non-interventional studies, registries, and chart abstractions.  Through these methods and by assembling the right project team drawn from our expert pool of survey experts, health economists, outcomes researchers, epidemiologists, biostatisticians, psychometricians, and drug safety leaders, we can help you with:

  • Burden/cost of Illness
  • Disease prevalence and incidence
  • Treatment patterns, impact, and adherence
  • Product safety and risk minimization evaluations (e.g., PASS, REMS)
  • Drug utilization studies
  • Pragmatic clinical trials
  • Time and motion
  • Patient-reported outcomes and health-related quality of life
  • Patient satisfaction

Study Design and Implementation

From consulting support to managing multi-national, multi-year, late-phase studies, we can help inform your regulatory, clinical, and market access decision-making. All projects are led by senior staff with extensive methodological and therapeutic experience who apply best practices and follow a systematic approach that includes:

  • Strategic planning
  • Protocol development
  • Advisory board set up and facilitation
  • Feasibility assessments
  • Regulatory and ethics submissions
  • Study materials development (e.g., questionnaires, case report forms, informed consent forms, and interview guides)
  • Data collection systems development, verification, and implementation
  • Site recruitment, contracting, training, and retention
  • Patient sampling, recruitment, and retention
  • Statistical analysis plans
  • Reports and publications

Data Collection and Management

Dependent upon your patient population demographics, disease areas, data types, geography, timeline, and budget, we select the most appropriate data collection tools and methods. We also follow procedures that are guided by ICH Good Clinical Practices, the International Society for Pharmacoepidemiology (ISPE), the FDA, the EMA, and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Our experience includes customizing and employing the following technologies:

  • Laptop and tablet applications
  • Electronic data capture (EDC) via the web
  • Smartphone data collection and transmission
  • Handheld electronic patient diaries
  • Audio computer-assisted self-interviewing (ACASI)
  • Interactive voice response system (IVRS)
  • Optical character recognition of paper data collection forms
  • Call center for contacting subjects via telephone

As part of our services, we liaise with RTI’s central IRB, develop data management plans, create and test data capture forms, develop data management systems and user acceptance procedures, and monitor quality. 

Recent Publications

Farrell K, Kim S, Han N, Iida MA, Gonzalez EM, Otero-Garcia M, Walker JM, Richardson TE, Renton AE, Andrews SJ, Fulton-Howard B, Humphrey J, Vialle RA, Bowles KR, de Paiva Lopes K, Whitney K, Dangoor DK, Walsh H, Marcora E, Hefti MM, Casella A, Sissoko CT, Kapoor M, Novikova G, Udine E, Wong G, Tang W, Bhangale T, Hunkapiller J, Ayalon G, Graham RR, Cherry JD, Cortes EP, Borukov VY, McKee AC, Stein TD, Vonsattel JP, Teich AF, Gearing M, Glass J, Troncoso JC, Frosch MP, Hyman BT, Dickson DW, Murray ME, Attems J, Flanagan ME, Mao Q, Mesulam MM, Weintraub S, Woltjer RL, Pham T, Kofler J, Schneider JA, Yu L, Purohit DP, Haroutunian V, Hof PR, Gandy S, Sano M, Beach TG, Poon W, Kawas CH, Corrada MM, Rissman RA, Metcalf J, Shuldberg S, Salehi B, Nelson PT, Trojanowski JQ, Lee EB, Wolk DA, McMillan CT, Keene CD, Latimer CS, Montine TJ, Kovacs GG, Lutz MI, Fischer P, Perrin RJ, Cairns NJ, Franklin EE, Cohen HT, Raj T, Cobos I, Frost B, Goate A, White III CL, Crary JF. Genome-wide association study and functional validation implicates JADE1 in tauopathy. Acta Neuropathol. 2022 Jan;143(1):33-53. doi: 10.1007/s00401-021-02379-z.