DSCS CLINICAL TRIAL SERVICES “On Time and Under Budget!”

We can manage every clinical project through all stages from concept to final report. We pride ourselves on taking over the more challenging trials and finding physicians who currently treat the target patient population while simultaneously training them and building their own infrastructure to conduct clinical trials.

Our Proven ModelHeadquartered in Southern California, we are a full service CRO that differentiates itself with our patient recruitment strategy for difficult to recruit studies, and with our low overhead and operating costs when it comes to the less demanding trials. We pass both of these benefits: cost savings and rapid patient enrollment, on to the Sponsor. While the lower costs are self explanatory (we simply do not have the overhead of most of our larger competitors), our patient recruitment strategy is unique and worth a brief explanation.

Patient EnrollmentThe problem with most studies, as you are aware, are slow recruitment rates amongst sites. The root of the problem, we believe, begins with site selection and PI recruitment. We reverse engineer the desired patient population and look for the physicians who treat a large volume of these patients across the country. Our business development team will contact the physician and partner with them on developing their own in house research department.

How It WorksUnlike the traditional SMO models of the past, our backbone is our network of home based CRA’s that we have trained internally, and whom are remotely working for us in every region of the country and are available for onsite monitoring as well as remote monitoring around the clock. At current count we have 44 trained CRA’s, 3 Project Managers, 5 Medical Monitors, and 4 Lead CRA’s. We also have a team dedicated to contracts and another dedicated to regulatory affairs. We assign each newly formed physician site their own CRA whose only job will be to monitor and help provide the necessary training and operational oversight to ensure that the PI and their study coordinators will have a successful first trial. We have even gone to the extent of hiring and training the study coordinator for the PI or assisting in hiring an already trained study coordinator. We have a full grasp of what it takes to operate a research site as we also own and operate other research clinics across the country through our other business units.

ServicesWhile we are a full-service CRO, we understand that many Sponsors prefer to choose certain services “à la carte”. We are looking to work with you on your more challenging trials and hope to be able to assist in the patient recruitment, site selection, site training, and monitoring oversight of these sites as we pride ourselves on specializing in working with research naive physicians. We also have a dedicated team that handles all of the back-end activities that any clinical trial will require, such as data analysis, site supply, investigational product logistics and accountability, and the like.

Clinical Trial Management – Set-up and Monitoring DSCS provides monitoring services that ensure your study is compliant with all GCP, ethical and regulatory requirements. DSCS has a highly trained team of CRAs to set-up and monitor your clinical trial starting with site feasibility and site selection including the preparation of confidentiality agreements and site contracts. The CRAs then work with the writing team to co-ordinate ethics and regulatory submissions. The next stage is organizing investigator meetings and conducting site initiation visits which are followed by regular monitoring according to the approved monitoring plan. Recruitment status and trial progress is tracked and CRAs maintain the electronic trial master file (eTMF) throughout before finally conducting site close out visits. At all times DSCS’s experienced CRAs work closely with the sites to ensure that your trial is conducted to the highest standards and recruitment objectives are met.

DesignWe are able to workshop ideas for your study with our team of experts. DSCS statisticians/biostatisticians can provide initial clinical trial design advice, sample size calculation and randomization schedules. Medical and scientific writers then provide the necessary documents with the necessary GCP/ICH standards (including the IB, protocol and informed consent) and our specialized team prepares all ethics documentation to meet submission timelines.

Past Performance/ExperienceWe have proven through our past decade of consulting experience that we are able to successfully identify, train, and encourage research naive physicians to conduct their first clinical research studies while not disrupting their private practice operations in the process. To date, all of the physicians whom we have set up a research operation for, have continued to participate in further research studies. Due to our existing infrastructure, we are able to maintain quality control while allowing the Investigative sites to operate independently of us. This is the main differentiator and what separates us from Site Management Organizations.

Risk Based Monitoring and Remote Monitoring

The next two slides will illustrate our biostatistics and data management components which work 24/7 behind the scenes to allow for necessary adjustments to be made to each site’s unique monitoring plan. Our home based monitors are trained on using our own customized EDC platform and CTMS systems provided by Bioclinica, as well as our virtual workspace provided by Intralinks. This allows for real time source data verification, in addition to an online eTMF which allows for seamless collaboration between data management, our CRA’s, the research site and the Sponsor. All systems are ICH and FDA 21 CFR Part 11 compliant.

Data Management DSCS provides the full range of data management services from data capture through validation and reporting. All of our experienced data managers have postgraduate qualifications in Data Management. We have also partnered with Bioclinica on their EDC platform. Our services include case record form (CRF) design (eCRF and ePRO), database set-up, double data entry, validation and generation of queries. Our MedDRA certified staff code medication, medical history and adverse events using the latest dictionaries and coding tools. Experienced coders use the WHO DD to code concomitant medications. All systems are ICH and FDA 21 CFR Part 11 compliant.

Statistics DSCS provides statistical consulting services to business, government and academia. DSCS employs statisticians/biostatisticians, with postgraduate qualifications in statistics. They regularly provide guidance in clinical trial design, provide a statistical analysis plan (SAP), perform statistical analyses in SAS, and provide tables, figures and listings which can be included in an ICH standard (E3) full clinical study report (CSR).

Medical and Scientific Writing DSCS provides specialized medical and scientific writing as well as editing services. Our multidisciplinary team of experienced writers have all been awarded the prestigious Certified Medical Publication Professional (CMPP) qualification and are the authors of peer-reviewed journal articles, book chapters, grant proposals and clinical study documentation. As an integral part of clinical research, our medical writers produce the necessary documents including protocol, IB, ethics and regulatory documents and the full CSR to ICH standards. Publications are produced to journal standards and presentations, scientific or technical documents, are written according to professional guidelines. Acknowledgements of authorship at all times comply with ICMJE guidelines.

Pharmacovigilance

DSCS provides pharmacovigilance services overseen by our medically qualified personnel who can provide safety oversight for clinical trials, including Data Safety Monitoring Board (DSMB) involvement, with full services offered for start-up companies.

QA and Auditing

DSCS can arrange independent quality assurance (QA) and GCP auditing and quality control of standard operating procedures (SOPs) anywhere in the world. Our auditor partner has internationally recognized qualifications and a wealth of experience.

THERAPEUTIC AREAS

· AIDS/HIV · alternate therapies · anti-infectives · cystic fibrosis · cardiovascular · diabetes · dermatology · devices · diagnostics · first-in-humans

· gastroenterology · hematology and immunology · mental health · musculoskeletal · neurology · oncology · ophthalmology · pain · respiratory – acute and chronic · reproductive technology

THE TEAM

DSCS boasts an integrated team of highly qualified and experienced professionals including medical, pharmacy and drug development, statistics and biostatistics, biological sciences, public health and IT graduates, most with postgraduate qualifications. At current count we have 44 trained CRA’s, 3 Project Managers, 5 Medical Monitors, and 4 Lead CRA’s.

STANDARDS

DSCS is committed to compliance with all international and local applicable regulatory requirements for managing clinical studies. All studies are conducted according to the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines. All our data collection systems are compliant with US Federal Drug Administration (FDA) code of regulations, Title 21 CFR Part 11. We have quality management systems in place to ensure excellent processes. Our systems are set up to ensure security and protect confidentiality and privacy.

EXPERIENCE

DSCS and its executive team have worked on 100s of studies over the past two decades. The two founders, Dan Sfera and Chris Sauber, have over two decades of experience managing hundreds of clinical trials as site owners, site directors, project managers, and consultants, amongst other capacities. We are a niche CRO that works exclusively with small to mid-sized biotech companies.

Please take a moment to visit our website DSCSsweatEquity.com to learn more about our capabilities or to request a proposal for an upcoming or existing trial.

Dan Sfera can be reached at (714) 318-5394 or at dan@theclinicaltrialsguru.com