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About Me
ANDREA LANG, CCRA
AML CONSULTING OF FLORIDA, LLC


PROFESSIONAL HIGHLIGHTS
� 16 years of experience in clinical research including project management, monitoring, study coordination, regulatory affairs and quality assurance
� Participation in approximately 200 phase I-IV studies

THERAPEUTIC AREAS
� Oncology, CNS, cardiovascular disease, HIV/infectious disease, allergy/immunology, dermatology, endocrinology, gastroenterology, gynecology, hematology, pulmonology, radiology and rheumatology

PROFESSIONAL EXPERIENCE
Independent Consultant Project Manager/Clinical Research Associate, USA, 2001�present
Multiple US-based CROs, UK-based CRO, Biotech

� Project management of early and late phase international, multi-center clinical studies, including protocol development consultation, project team management, trial set-up and delivery management, selection of subcontractors, budget and contracts management and negotiations, and customer liaison
� Development and execution of project-specific and general site and CRA training
� Clinical site management
� Management and resolution of trial issues (i.e., project risk assessment, trouble-shooting, and problem solving)
� Management and coordination of data management teams, including the design, development, and use of Case Report Forms (CRFs) and supplemental data collection tools (including Electronic Data Capture packages)
� Field monitoring and supervisory co-monitoring

Dekalb Neurology Associates, LLC, Atlanta, GA, USA 1999-2001
Clinical Research Manager
Overall management of a large clinical research site, including:
� Recruitment and supervision of investigators, study nurses and ancillary site support staff
� Establishment and management of Quality Assurance, including the development and implementation of Standard Operating Procedures (SOP)
� Clinical Research Coordination and Regulatory Affairs Management
� Business Development and customer management services
� FDA and Sponsor audit preparation and management
� Financial and study tracking

Independent Consultant Clinical Research Associate//Regulatory Auditor, USA 1997-1999
Multiple US-based CROs

� FDA and Sponsor audit preparation and management
� Site/study management consulting services
� Development and implementation of SOPs
� Financial and study tracking system development and implementation
� Quality Assurance
� Clinical Research Coordinator and Regulatory Affairs training and management
� Field monitoring and supervisory co-monitoring

Clinimetrics Research Associates, Inc., Atlanta, GA, USA 1996-1997
Clinical Research Assistant
� Organization and maintenance of regulatory documents
� Monitoring report review and tracking
� Assistance with site registration
� Development and maintenance of study databases and spreadsheets
� Processing of completed CRFs prior to data entry
� Data clarifications

InSite Clinical Trials, Inc., Atlanta, GA., USA 1995-1996
Data Resource Manager/Clinical Trial Monitor
� Coordination of patient recruitment and CRF completion across 60 research sites nationwide
� Development of a centralized fax-based CRF completion system, including software, process maps, to facilitate a 48 hour CRF turn-around time
� Development, recruitment, and management of clerical and clinical transcription personnel to support study nurses
� Performance of internal Quality Assurance for FDA and Sponsor audits

InSite Clinical Trials, Inc., Atlanta, GA, USA 1993-1995
Senior Clinical Data Coordinator/Clinical Trial Monitor
� Multiple clinic coordination including study implementation, patient recruitment/enrollment, data collection, patient scheduling, and physician/hospital staff in-services
� Quality Assurance
� Development of a Clinical Data Coordinator Training Program and training manual

TRAINING
� Federal regulations and GCP/ICH guidelines (multiple providers), 1993 � present
� Regulatory and Compliance Certificate Program (San Francisco State University)
� GCP I � Introduction to Good Clinical Practice, 2007
� GCP II � GCP in Practice, 2007
� 21CFR Part 11, 2007
� Basic and advanced clinical coordination (Barnett International), 1994 and 1995
� CRA-focused successful site management  (Association of Clinical Research Professionals), 2000
� NIH Stroke Scale (multiple providers), 1994-2001
� Monitoring Electronic Medical Records (US CRO), 2004, 2007
� HIPAA guidelines (US CRO), 2004, 2007
� HIPAA guidelines (US Sponsor), 2004
� Investigator Site Electronic Medical Records and FDA IND 21 CFR11 Regulatory Compliance (US CRO), 2004, 2007
� Oracle Clinical Remote Data Capture (US Sponsor), 2007
� Clinical Research Associate Certification (Association of Clinical Research Professionals), 2008
� Certificate � Regulatory and Compliance (San Francisco State University � pending completion)

MEMBERSHIPS
� Association of Clinical Research Professionals
� Society of Clinical Research Associates
Andrea Lang, CCRA
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Name: Andrea Lang, CCRA
Email: Andrea Lang

Partial Trial Listing

Phase III study using a GPIIB/IIIA receptor antagonist to prevent recurring Stroke, TIA or MI

Phase III monotherapy study using an anti-epileptic in patients with new onset or recurrent seizure

Phase III study using an anti-epileptic for treatment of diabetic peripheral polyneuropathy

Phase III in-patient study using a neuroprotectant in treatment of patients with acute ischemic stroke

Phase III in-patient study using a potassium channel opener in patients with acute ischemic stroke

Phase IV multitherapy study using anti-epileptics in patients with recurrent seizures

Phase III study using an anti-epileptic for treatment of diabetic peripheral polyneuropathy

Phase III study using a selective noncompetitive AT1-subtype angiotensin II receptor antagonist without agonist activity in the treatment of patients with hypertension

Phase III study using a B2-adrenoceptor agonist in the treatment of mild to moderate asthma

Phase III study using a Leukotriene receptor antagonist in the treatment of mild to moderate asthma

Phase II study using synthetic peptides in the treatment of cat-allergic patients Phase III comparator study using a B2-agonist in the treatment of moderate to severe asthma

Comparator and an open, Phase III, studies using liposomal chemotherapy in the treatment of moderate to severe Kaposi�s Sarcoma in AIDS

Two-arm, Phase III, comparator study using combination therapy with two anti-tubercular drugs and a macrolide antibiotic in the treatment of Mycobacterium Avium Complex Bacteremia in AIDS

Open, Phase III, study using a synthetic anti-fungal in the treatment of oropharangeal candidiasis in HIV + patient

Open, Phase IV, hydration study in AIDS patients with CMV Retinitis

Open, Phase III, in-patient study using a narcotic antagonist in patients with acute ischemic stroke

Comparator and open label Phase III studies using non-benzodiazepines in the treatment of patients with primary insomnia or insomnia associated with mild non-psychotic psychiatric disorders

Phase II, in-patient/outpatient study using an anti-protozoal in the treatment of mild to moderate Pneumocystis Carinii Pneumonia in AIDS

Phase III in-patient study using exogenous CDP-choline in patients with acute ischemic stroke

Phase III study using a DNase derivative in patients with COPD

Phase III study using a 5-HT1 antagonist in patients with migraines

Phase III study using a quinolone in patients with osteomyelitis

Phase II, in-patient, comparator study using a streptogramin in patients with community-acquired pneumonia

Phase IV study using a cephalosporin in patients with acute bronchitis

Phase III study using a fluoroquinolone in patients with community-acquired pneumonia

Phase III study using a fluoroquinolone in patients with acute sinusitis

Phase II/III study using a quinolone in patients with acute bronchitis

Phase II/III, in-patient study using a quinolone in patients with patients with community-acquired pneumonia

Phase II study using hormonal agent in the treatment of metastatic breast cancer

Phase III study using liposomal chemotherapy in the treatment of metastatic breast cancer

Phase III study using IV and oral chemotherapy in the treatment of metastatic colorectal cancer

Phase IV, comparator study using 5-HT3 antagonists in patients receiving highly emetogenic chemotherapy

Phase III, dose response study using an anti-epileptic for migraine prophylaxis

Phase III study using a statin for prophylaxis of cerebrovascular events in patients with history of cerebrovascular accident and transient ischemic attack

Phase II, in-patient, dose response study using a postassium channel moderator in the treatment of acute ischemic stroke

Phase II study using an Angiotensin Receptor Blocker in the treatment of moderate hypertension

Phase III study using an Angiotensin Receptor Blocker in the treatment of moderate hypertension

Phase III endpoint study using an Angiotensin Receptor Blocker in the treatment of Congestive Heart Failure

Phase II, double-blind, randomized, placebo-controlled, proof-of-concept study of the efficacy, safety, and tolerability of a Thiazolidinedione in combination with an Angiotensin Receptor Blocker in the treatment of Type II diabetes

Phase III/IV, randomized, parallel group, multi-national, double-blind, double-dummy, active and placebo controlled, 2x2 factorial study comparing two Platelet Inhibitors in combination with an Angiotensin Receptor Blocker to prevent recurrent stroke

Phase III, double-blind, parallel group, placebo-controlled study using a V-Protectant to reduce clinical events in atherosclerotic subjects

An open-label, randomized, crossover study to assess preference of two devices in rheumatoid arthritis subjects

Phase II, randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, and immunogenicity of a vaccine in healthy adults

Phase IV, multicentre study to describe the immunogenic Epitope(s) of FVIII in previously treated patients with congenital hemophilia A who develop factor VIII inhibitors while receiving FVIII infusion therapy

A retrospective study to describe the incidence of moderate to severe allergic reactions to Factor IX in patients with hemophilia B

Phase II, randomized, multicentre, double-blind, placebo-controlled, crossover study to assess the efficacy of two doses of a benzodiazepine derivative in the treatment of primary insomnia in adult patients

Phase II, randomized, multicentre, double-blind, placebo-controlled, parallel group study to assess the hypnotic efficacy of a benzodiazepine derivative in the treatment of primary insomnia in elderly patients with daytime sleepiness

Phase II, placebo-controlled, double-blind, parallel group comparison of a phosphate binder in hemodialysis subjects with hyperphosphatemia

Phase II, open-label, multicentre, in-patient study to investigate the efficacy and tolerability of a narcotic nasal solution for the relief of breakthrough pain in cancer patients

Registry to improve the use of evidence-based Heart Failure therapies

Phase II, randomized, double-blind, placebo-controlled and parallel group study to evaluate the safety and efficacy of an inhibitor in patients with COPD associated with chronic bronchitis

Phase IV, multicentre study to evaluate the effectiveness and tolerability of a narcotic for chronic moderate to severe pain: a focus on risk minimization, intervention, and outcomes

Phase III, efficacy and safety study of an oral treatment for NMM Cystic Fibrosis

Phase III, efficacy and safety of an ophthalmic solution vs. placebo for treatment of ocular inflammation and pain, associated with cataract surgery

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