Clinical Research Team
For best results, trust us with your next clinical trial
Our team of experienced clinical operations professionals has the necessary expertise and understanding of the medical industry’s complex clinical trial development and management process to successfully support your clinical trial efforts, from concept inception, through all phases to post-approval.
Our specialized team of clinical consultants can support clinical trials in all healthcare industry from device and software, IVD to drugs, biologics, and to combination products and has led numerous clinical trials in different therapeutics areas (see bios and details below).
Jerika Acosta - Director of Clinical Operations
L. Adelina Paunescu, Ph.D. - Managing Partner, Vice President of Clinical Services
Our statisticians have many years of clinical research experience, successfully performing, developing, and directing Biostatistics, Statistical Programming and Data Management activities as it relates to Clinical Research and Quality Assurance in Pharmaceutical, Biotech, Medical Device and CRO companies. Areas of expertise include all forms of study design (frequentist, adaptive, sequential trials, Bayesian, surveys, stability, shelf life, etc.), complex statistical methodology, sample size determination, data collection, and statistical programming (SAS).
Our device statistician is a well-versed when interacting with regulatory bodies, leading and supporting numerous 510(k), IDE and PMA submissions from initial Pre-Submission Meetings to Panel Reviews and successful approval.
Our pharma statistician brings experience in clinical and CMC statistics and has worked with both medical device and pharmaceutical FDA regulated companies.
Our Data Manager brings over 10 years of industry experience in Phase I-IV pharmaceutical and Device clinical trials, in CRO, sponsor, pharma, device, and academic environments. He supported several projects in data management, clinical operations, and safety. He has experience with multiple Electronic Data Capture.
Data & SAS Programmers
Our programmers are expert and certified SAS Programmers, with expertise in SAS Macros, in pharmaceutical and medical device industry clinical trials and post-market studies. He had responsibility for the design, implementation, documentation and refinement of tools and processes that streamline SAS development activities for TLF creation/validation, SDTM/ADaM metadata management, and submission staging/validation. Significant CDISC standards expertise (SDTM, ADaM and Define.xml), including specification creation, dataset creation and validation. Submission experience including staging, validation, and preparing associated documentation. TLF creation and validation for Phase II-IV studies, as well as ad hoc programming support for time-critical publication requests. Extensive experience with safety and efficacy data, measures and analyses, genotyping/genomic data, QOL indicators, medical and diagnosis coding dictionaries. Experienced with CDISC standards, ADaM and SDTM models, define.xml generation and validation.
MEDIcept has multiple experienced CRAs who can serve as monitors to support various clinical trials in different geographical areas. MEDIcept works with the client to identify the best CRAs based on the product therapeutic area and clinical trial design needs. Our CRA team expertise spans over many years of pharmaceutical and device experience (see a few examples).
Lead CRA/Project Manager
Lead/Senior Clinical Research Associate with over 25 years of pharmaceutical and device experience of clinical trial conduct – clinical trial monitoring, site management, project management, auditing, and writing. Through coordination of the clinical monitoring process in accordance with ICH Guidelines Good Clinical Practice (E6 R2), FDA Code of Federal Regulations, Good Clinical Practice and applicable local regulations, she monitors and manages clinical research sites with a reassuring sense of ease. Therapeutic areas include: Medical device trials have included Class III (LVAD); Pharmaceutical trials have included Phase I-IV programs in Cardiology (Hypercholesterolemia; Antiplatelet); Dermatology (Psoriasis; Acne); Hematology (PCR Assay); Immunology (Chronic Gout); Musculoskeletal (Arthritis); Neurology (Pain – Schedule II; Narcolepsy – Schedule IV; Epilepsy – Schedule I / V); Oncology (Breast; Prostate; Colorectal; Lung); Ophthalmology (DME; AMD; IOP; Dry Eye; Contact Lens); Psychiatry (Schizophrenia); Pulmonary (Fibrosis; Sclerosis; PAH; COPD); Urology (Overactive Bladder); and Rare Disease (GM2 Gangliosidosis (Tay-Sachs and Sandhoff disease); Niemann-Pick disease Type C (NPC)).
Senior CRA/Project Manager
Clinical Project Manager with over 20 years of clinical-research experience in the pharmaceutical and medical device arena. He started his career within the in-vitro diagnostic industry as a chemist at Abbott Laboratories. He is experienced in set-up and management of clinical research operations for multi-national phase I-IV clinical trials. He has a Site and Project Management background inclusive from site feasibility and initiation, regulatory start-up, monitoring and management, through close-out. He successfully collaborated in the clinical development of pharmaceutics, medical devices, and biotech products within Pharma and CRO settings. He has experience in the following therapeutic areas: In-vitro Diagnostics; Medical Devices: Cardiovascular (Drug Eluting Stents, LVAD), Transplants (Heart, Lung, Liver); Pharmaceutical: Cardiovascular (arrhythmia, hyperlipidemia, hypertension, heart failure), Endocrinology (diabetes), Infectious Disease (hepatitis, HIV), Neurology (pain, Parkinson’s, sleep disorders), Psychiatry (depression, schizophrenia), Pulmonary (COPD, ILD, IPF), Ophthalmology (diabetic retinopathy);
CRA with twenty-two years in clinical research with unparalleled expertise in human clinical trials from PK/first-in-human through Phase IV. Experienced in various healthcare industry: pharmaceutical, biotech and device industry, and CROs/AROs. Conducted pre-study visits through close-out visits at investigative sites. Conducted source document verification of CRFs against medical records, investigational product accountability, review investigator study file(s) and reconcile to trial master file(s), performed safety reviews/SAE reconciliations. Evaluated data query trends and interact with study team in order to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA. Identified site issues, ensured proper escalation, if necessary, and ensured resolution.
MEDIcept has experienced medical professionals who can serve as safety officers and medical monitors to support safety monitoring as required for various clinical trials. MEDIcept can assist in selecting members and managing the process of Clinical Events Committee (CEC) and Data and Safety Monitoring Boards (DSMB) and Data Monitoring Committees (DMC) for clinical trials.
Skilled medical writer covering all phases of clinical research and in various therapeutic areas. Significant experience in writing of regulatory documents such as Clinical Evaluation Report, Clinical Study Report, Protocols, Summaries, and Post Market Surveillance plans and reports compliant with EU MDR. Conduct literature searches to support post market activities, EU MDR/MDD SME gap analysis and corporate educator for compliance.
Experienced professional in regulatory, medical information, and publications writing for drugs, biologics, and devices. Regulatory medical writing support of several IND, NDA, MAA submissions. Managed the writing and completion of documents within established timelines and with high quality scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes (including ICH, GCPs, PhRMA, GPPs, and ICMJE).