Pharma Lynx Data Management, Pharmacovigilance, Drug Safety, Medical Monitoring, Clinical Monitoring, Biostatistics, Regulatory, Medical Writing, Patient Recruitement.
There are hundreds of CROs in the USA and thousands internationally. So when is the best time to access Princeton based Pharma Lynx, LLC?The answer is as easy as 1 2 3 1 If you’re planning a Phase I-II study and want to lower 2 If you’re planning to design a QTc study for a cancer trial your drug development costs The QTc Study and Pharma Lynx: Phase I-II clinical trials: The US Food and Drug Administration (FDA) requires a QTc study for all new chemical enti- Pharma Lynx is uniquely positioned to help ties in order to evaluate the cardiac safety of you design, manage and deliver on your study cancer and non-cancer drugs. The focus is on because of our strong ground resources in both cardiac repolarization as measured by the du- the US and India - and our thorough under- ration of the QT interval in serial electrocar- standing of regulatory issues. Our reputation is diograms (ECG). built on our oncology experience and expertise. But we’re gaining ground and recognition in With few exceptions, all compounds being sub- other therapeutic areas such as, CNS, Vaccines mitted to the FDA for approval in the United and Infectious diseases. So if you’re planning a States will require an assessment of QT prolon- trial in any of these categories then it makes gation either by thorough QT/QTc study, or a sense to call Pharma Lynx. study modified to fit the safety profile of the compound and indicated cancer patient popu- Our in-house oncology expertise is recognized lation. The arrhythmia at any one time may as world-class. The team is highly skilled in present with no symptoms, or with palpita- working with the indications listed below: tions, dizziness, syncope, sudden death or Tor- A Sample of Indications sade de Pointes “Twisting of the Points”, which is a potentially fatal arrhythmia associated Solid (Non-hematologic • Urinary bladder with prolongation of the QT interval on the malignancies) • Other sites • Breast Blood (Hematologic malig- ECG. The concomitant administration of med- • Brain and other nerv- nancies) ications with a QT prolonging effect can result ous system • Non-Hodgkin’s lym- • Colon and rectum in incremental QT prolongation. phoma • Cervix • Leukemia How and when QTc assessments are performed • Kidney and renal Supportive care: are critical clinical, business and financial questions. pelvis • Oral mucositis • Lung and bronchus • Xerostomia At Pharma Lynx, we possess ALL the clinical, • Liver and intrahepatic • Nausea/vomiting bile duct • Constipation/Diarrhea operational and regulatory expertise that will • Melanoma • Depressive Mood help you answer these questions. Our in-house • Ovary • Hot Flashes experts have great experience and insights on • Oral cavity and phar- • Pain ynx developing the study design and protocol. Ad- • Treatment-related • Prostate Anemia ditionally, we’re there with you, as needed for • Pancreas FDA meetings and teleconferences. HQ: 300 Alexander Park, Suite #200 Princeton, NJ 08540 United States
3 Pharma Lynx’s biostatisticians and statistical If you need clinical data programmers have all earned advanced aca- management or expert demic degrees and have spent multiple yearsbiostatisticians working in the pharmaceutical industry. All staff members are cancer clinical trial special-Pharma Lynx delivers high-quality, cost-ef- ists, both from an industry and CRO perspec-fective solutions to ensure the successful tive. Our breadth of experience and depth ofmanagement and delivery of clinical trial knowledge- combined with exposure to multi-data- AND we fully understand the com- ple treatment paradigms translates into aplexities surrounding data management in team that is recognized as world class. Our bio-the oncology setting. The challenges in statisticians are frequently invited as speakersusing RECIST in cancer trials are antici- to key industry meetings, underlying our ex-pated and best efforts are utilized to pertise in the evolving areas of efficient studyavoid any errors. designs and complex analysis methods.We lead the way in the use of the technologies Our core services include the following:and standards and our Data Managers areproficient in the use of a wide range of tech- Statistical Analysisnologies including Electronic Data Capture I Statistical Analysis Plans, including(EDC), Oracle Clinical®, Phase Forward and mock production of Table, Listing andMedidata RAVE. Figure displaysOur experience and understanding of Elec- I Detailed documentation translating thetronic Data Capture (EDC) processes and sys- Analysis Plan into a responsive and accuratetems enables us to provide the optimum programming effortsolution for each project. We offer a full range I Generation of analysis datasets using indus-of EDC services that can be combined to meet try standard format conventionsvirtually any need. Our expert certified re-sources work with customers internally and ex- I SAS® production of Table, Listing and Figureternally to ensure each trial is developed to the displays for use in clinical study reports orhighest standards using the latest technologies other summary activitiesavailable in the marketplace. Data Interpretation and ReportingOur Data Managers are also trained in the use I Interim analyses, including coordinationof the latest standards including CDISC. We em- with Data Safety Monitoring Boardsploy these standards to enable efficient review, I Stand alone statistical reportsprocessing transmissions and submission ofdata to the regulatory authorities. We continue I Interpretation, writing, and review of finalto build an impressive portfolio of experience in clinical reportsthe use of the various CDISC models including I Ad hoc analysisSDTM and Analysis Data Model (ADaM). I Data mining To learn more about how we will help to improve your business results- Please contact Ashok Srivastava, Chief Medical Officer. Phone: 732-694-3394 Email: email@example.com HQ: 300 Alexander Park, Suite #200 Princeton, NJ 08540 United States